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

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT INVOLVING KIT FLU A+B 30 TEST PHYSICIAN VERITOR. THE CUSTOMER REPORTED THAT THE BLACK SPOTS WERE FOUND WHEN REAGENTS WERE DROPPED IN THE READING AREA, WHICH CAUSING ABNORMAL READINGS. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BHR (BATCH HISTORY REVIEW) ANALYSIS AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. THE CUSTOMER HAS PROVIDED A PHOTOGRAPH CONFIRMING BLACK SPOT IN THE TEST WINDOW OF CARTRIDGE. ADDITIONALLY, ANOTHER PHOTOGRAPH OF VERITOR FLU TEST RESULT TAKEN WITH A VERITOR READER WAS PROVIDED BY THE CUSTOMER. THE TEST RESULT INDICATED A POSITIVE FOR FLU A, BUT THE PCR RESULT WAS NEGATIVE. THIS COMPLAINT WAS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE. THE ROOT CAUSE COULD NOT BE DETERMINED. A TREND ANALYSIS FOR FALSE POSITIVE AND CONTAMINATION / FOREIGN MATTER WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA: 11910483.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, CONTAMINATION ON THE TEST DEVICE LED TO A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.