STAT PROFILE CRITICAL CARE XPRESS

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Description of Event or Problem

USER FACILITY REPORTED ON (B)(6) 2009, SEVENTEEN PTS HAD BEEN ADMITTED TO THEIR FACILITY BASED ON CREATININE VALUES FROM THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER BETWEEN THE DATE OF RANGES OF (B)(6) 2008 TO (B)(6) 2008. PER THE USER FACILITY, WITHIN 24 HOURS OF ADMITTANCE, THE PT'S BLOOD WAS TESTED ON THE MAIN CHEMISTRY ANALYZER. THE MAIN CHEMISTRY ANALYZER REPORTED CREATININE VALUES THAT WERE LOWER THAN THE ORIGINAL REPORTED VALUES FROM THE CRITICAL CARE XPRESS ANALYZER.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

Additional Manufacturer Narrative

NOVA BIOMEDICAL HAD NOT BEEN CONTACTED ABOUT THE REPORTED EVENT BY THE USER FACILITY DURING NUMEROUS PHONE CALLS INTO THE TECHNICAL SUPPORT HOTLINE DURING THE REPORTED TIMEFRAME. THE EVENT WAS INITIALLY REPORTED TO NOVA BIOMEDICAL AFTER A PT ADMISSION REVIEW BY THE USER FACILITY. THE USER FACILITY HAS COMMUNICATED TO NOVA BIOMEDICAL THE FOLLOWING INFO ON (B)(6) 2009 REGARDING THE ADMITTED PTS: "(B)(6) AND I ((B)(6), HAVE REVIEWED THE MEDICAL RECORDS FOR THE 17 PTS THAT WE ADJUSTED THE DRG AND NONE OF THEM HAD SIGNS OF HARM (CHF OR PULMONARY EDEMA FROM IV FLUIDS) FROM THE FALSELY ELEVATED CREATININE." ALSO THE USER FACILITY COMMUNICATED THAT THEY ANALYZED 35-40 SPECIMENS PER DAY THROUGH THE AFFECTED ANALYZER THAT WOULD HAVE INCLUDED CREATININE. NOVA BIOMEDICAL OPENED CUSTOMER COMPLAINT (B)(4) TO REVIEW THIS EVENT. AS PART OF THAT REVIEW A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE CCX CREATININE MEMBRANES THAT WERE REPORTED TO BE IN USED DURING THE EVENT. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. ALSO NOVA BIOMEDICAL PERFORMED AN INVESTIGATION OF THE AFFECTED MEMBRANES USING PRODUCT RETAINS. THE INVESTIGATION REPORT BY (B)(6) CONCLUDED THAT MEMBRANES MET SPECIFICATIONS. THE WHOLE BLOOD DATA FROM THE INITIAL TESTING MET SPECIFICATIONS. THE RETAIN MEMBRANES WERE INSTALLED ON CCX ANALYZERS AND CALIBRATED AND QUALIFIED. THE WHOLE BLOOD TESTING ON THESE MEMBRANES MEETS THE PRODUCT SPECIFICATIONS. NOVA BIOMEDICAL (B)(4) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.