BD FACSCANTO¿ II

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER FSC & SSC SIGNAL SHIFT TOWARD THE ORIGIN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE IS PHANTOM AIR COLLECTING IN THE FLOW CELL DURING SAMPLE ACQUISITION CAUSING THE SCATTER PLOT TO SHIFT TOWARD THE ORIGIN AXIS. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED): YES. 2.WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131. G.1 - REPORTING OFFICE CONTACT - FAHMY RAZAK. G.1 - MANUFACTURING SITE CONTACT - FAHMY RAZAK. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE FSC AND SSC SIGNAL SHIFT WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE OF THE FSC AND SSC SIGNAL SHIFT WAS LOOSE AIR FITTING FOR THE TUBE EJECT MECHANISM THE CUSTOMER REPORTED A COMPLAINT REGARDING FSC & SSC SIGNAL SHIFT TOWARD THE ORIGIN. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SERVICE VISIT. THEY FOUND A LOOSE QUICK DISCONNECT FITTING FOR THE TUBE EJECT MECHANISM AND PERFORMED A TIGHTENING. AFTER THE REPAIR, THE INSTRUMENT WAS TESTED AND WAS MEETING SPECIFICATION. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS IDENTIFIED AND RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. NEITHER THE CUSTOMER NOR ANY PATIENTS WERE HARMED DUE TO THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Additional Manufacturer Narrative

E.1 (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER FSC & SSC SIGNAL SHIFT TOWARD THE ORIGIN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE IS PHANTOM AIR COLLECTING IN THE FLOW CELL DURING SAMPLE ACQUISITION CAUSING THE SCATTER PLOT TO SHIFT TOWARD THE ORIGIN AXIS. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED): YES 2.WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO