BD FACSLYRIC¿

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- MDR. G.1 - MANUFACTURING SITE CONTACT - FAHMY RAZAK - MDR. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR LOW VACUUM PRESSURE AND BEING OUT OF RANGE WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE FOR LOW VACUUM PRESSURE AND OUT OF RANGE IS DUE TO A WORN ASPIRATOR PUMP. FURTHER ALIGNMENT AND CALIBRATION WAS PERFORMED FOR THE INSTRUMENT TO RUN AS EXPECTED. THE DHR WAS REVIEWED TO ENSURE THAT THE INSTRUMENT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. 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. 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.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER PRESSURE FLUCTUATIONS CAUSED ERRONEOUS RESULTS ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VACUUM PRESSURE IS OUT OF RANGE (4.90 PSI) PATIENTS RESULTS ARE SHIFTED AND UNACCEPTABLE, THE ANALYZER IS COMPLETELY DOWN". ¿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

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 FACSLYRIC¿ FLOW CYTOMETER PRESSURE FLUCTUATIONS CAUSED ERRONEOUS RESULTS ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VACUUM PRESSURE IS OUT OF RANGE (4.90 PSI) PATIENTS RESULTS ARE SHIFTED AND UNACCEPTABLE, THE ANALYZER IS COMPLETELY DOWN". ¿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