KIT FLU A+B 30 TEST PHYSICIAN VERITOR

Additional Manufacturer Narrative

MEDICAL DEVICE LOT #: 0121654 WAS REPORTED, HOWEVER, THIS IS NOT A LOT NUMBER MANUFACTURED FOR THE REPORTED CATALOG NUMBER. INITIAL REPORTER PHONE #: (B)(6) OPTION 1 A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE KIT FLU A+B 30 TEST PHYSICIAN VERITOR, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE SPECIMEN IS NOT FLOWING COMPLETELY IN THE TEST DEVICE WHICH WILL RESULT IN FALSE POSITIVE FLU B. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: REVIEW THE WORK FLOW WITH THE CUSTOMER THEY SEEM TO WAIT 1 MINUTE LONGER SO THE SPECIMEN FLOW BEFORE READING IT. QC PASS. CUSTOMER DENIES ANY VISCOSITY IN THE SPECIMEN. THEY DON'T PERFORM THE TEST UNDER THE HOOD OR WHERE IS AN AIR FLOW. THEY TEST ON ANALYZE NOW MODE. SPECIMEN FLOW IS DELAYED AND FLOW SLOWLY. AFTER THE 10 MIN INCUBATION THE SPECIMEN FLOWS COMPLETELY AND THEY CAN SEE THE CONTROL LINE BUT THE BACKGROUND IS PINKISH AND ONCE THEY INSERTED IT GIVES FALSE POSITIVE ON FLU B. SHE STATES IF THEY REINSERT THE TEST LIKE 3 MIN LATER IT WILL GIVE NEGATIVE RESULTS. CUSTOMER STATES THAT THIS HAPPENED WITH THIS LOT ONLY AND THAT THEY ARE RUNNING A DIFFERENT LOT NOW AND IT WORKS FINE.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULT WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER 0121654. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE RESULT COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED FOR RETAIN AND RETURN SAMPLES WITH EXPECTED RESULTS. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE KIT FLU A+B 30 TEST PHYSICIAN VERITOR, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE SPECIMEN IS NOT FLOWING COMPLETELY IN THE TEST DEVICE WHICH WILL RESULT IN FALSE POSITIVE FLU B. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: REVIEW THE WORK FLOW WITH THE CUSTOMER THEY SEEM TO WAIT 1 MINUTE LONGER SO THE SPECIMEN FLOW BEFORE READING IT. QC PASS. CUSTOMER DENIES ANY VISCOSITY IN THE SPECIMEN. THEY DON'T PERFORM THE TEST UNDER THE HOOD OR WHERE IS AN AIR FLOW. THEY TEST ON ANALYZE NOW MODE. SPECIMEN FLOW IS DELAYED AND FLOW SLOWLY. AFTER THE 10 MIN INCUBATION THE SPECIMEN FLOWS COMPLETELY AND THEY CAN SEE THE CONTROL LINE BUT THE BACKGROUND IS PINKISH AND ONCE THEY INSERTED IT GIVES FALSE POSITIVE ON FLU B. SHE STATES IF THEY REINSERT THE TEST LIKE 3 MIN LATER IT WILL GIVE NEGATIVE RESULTS. CUSTOMER STATES THAT THIS HAPPENED WITH THIS LOT ONLY AND THAT THEY ARE RUNNING A DIFFERENT LOT NOW AND IT WORKS FINE.