BD FACSCANTO¿ II FLOW CYTOMETER

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. INITIAL REPORTER ADDRESS 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 ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.). YES. CLUSTERS NOT PROPER IN SAMPLES.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, DHR REVIEW, RISK ANALYSIS, AND SERVICE ACTIVITY REVIEW, COMPLAINT WAS CONFIRMED. THE INVESTIGATION WAS PERFORMED AND THE POTENTIAL CAUSE OF THE REPORTED COMPLAINT WAS IMPROPER CLUSTERS IN SAMPLES. THE ISSUE WAS RESOLVED WITH SHEATH FILTER PURGE, RUNNING FLUIDIC START-UP AND DEGASSING THE FLOWCELL TWICE. THE FSE CONFIRMED THE INSTRUMENT IS RUNNING AS EXPECTED WITH NO FURTHER ERRONEOUS RESULTS. NO PATIENTS WERE TREATED OR HARMED FROM INCORRECT RESULTS, AND THERE WAS NO DELAY IN PATIENT TREATMENT. TECHNICALLY THERE IS NO ISSUE. THERE WAS NO RISK OR SAFETY IMPACT TO USER OR PATIENT HEALTH OR SAFETY. 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 ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. CLUSTERS NOT PROPER IN SAMPLES.