BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN UPDATED WITH ADDITIONAL INFORMATION: . DEVICE AVAILABLE FOR EVALUATION: YES RETURNED TO MANUFACTURER ON: 15-APR-2024 INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVES WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 2353030. THE CUSTOMER REPORTED THAT THEY WERE RECEIVING POSITIVE RESULTS WITH PATIENT SAMPLES USING THE VERITOR ANALYZER. THEY THEN SUBMITTED THE SAMPLES FOR CONFIRMATORY PCR TESTING AND RECEIVED NEGATIVE RESULTS. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO PHOTOS WERE RECEIVED. RETURN SAMPLES WERE RECEIVED ON THE BATCH NUMBER PROVIDED AND THE RESULTS WERE ACCEPTABLE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS ON A REGULAR BASIS FROM SEPTEMBER 2023 THROUGH JANUARY 2024. PATIENTS WERE TREATED WITH TAMIFLU UNTIL PCR TESTING CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE NOT KEPT A LOG ON THESE NUMBERS. IT WAS ACTUALLY SEPTEMBER WHEN WE NOTICED A DISCREPANCY IN THE TEST RESULTS. THERE WERE A DOZEN OR SO FLU TESTS THAT SHOWED POSITIVE BY THE BD ANALYZER BUT WERE ACTUALLY NEGATIVE. IN DECEMBER ALMOST HALF THE TESTING DONE HAD FALSE RESULTS. IT WAS DECIDED AT THE BEGINNING OF JANUARY TO STOP USING THE ANALYZER ALTOGETHER. THERE WERE PARTICIPANTS WHO RECEIVED FALSE POSITIVE RESULTS AND WERE STARTED ON ANTI-VIRALS SUCH TAMIFLU. THEY WERE TOLD TO DISCONTINUE THAT MEDICATION AS IT WOULD NOT WORK UNLESS THEY ACTUALLY HAD THE FLU. SINCE THE PCR SHOWED THEY DID NOT HAVE THE FLU, THEY DISCONTINUED THE MEDICINE. THAT WAS DROPPED AS SOON AS THE PCR RULED IT A NEGATIVE FOR FLU."

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS ON A REGULAR BASIS FROM (B)(6) 2023 THROUGH (B)(6) 2024. PATIENTS WERE TREATED WITH TAMIFLU UNTIL PCR TESTING CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE NOT KEPT A LOG ON THESE NUMBERS. IT WAS ACTUALLY SEPTEMBER WHEN WE NOTICED A DISCREPANCY IN THE TEST RESULTS. THERE WERE A DOZEN OR SO FLU TESTS THAT SHOWED POSITIVE BY THE BD ANALYZER BUT WERE ACTUALLY NEGATIVE. IN DECEMBER ALMOST HALF THE TESTING DONE HAD FALSE RESULTS. IT WAS DECIDED AT THE BEGINNING OF (B)(6) TO STOP USING THE ANALYZER ALTOGETHER. THERE WERE PARTICIPANTS WHO RECEIVED FALSE POSITIVE RESULTS AND WERE STARTED ON ANTI-VIRALS SUCH TAMIFLU. THEY WERE TOLD TO DISCONTINUE THAT MEDICATION AS IT WOULD NOT WORK UNLESS THEY ACTUALLY HAD THE FLU. SINCE THE PCR SHOWED THEY DID NOT HAVE THE FLU, THEY DISCONTINUED THE MEDICINE. THAT WAS DROPPED AS SOON AS THE PCR RULED IT A NEGATIVE FOR FLU."

Additional Manufacturer Narrative

G5. MULTIPLE 510(K): K112277, K132259, K132692, K151291, K152870, K160161 H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.