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

Additional Manufacturer Narrative

G.5. PMA / 510(K)#: THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED: K132259, K132692, K151291, K152870, K160161 INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 2352688. THE CUSTOMER REPORTED THAT THEY ARE SEEING LINES ON THE DEVICE BUT RECEIVING NEGATIVE RESULTS ON THE VERITOR ANALYZER. 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 PHOTOGRAPHS OR RETURN SAMPLES WERE RECEIVED; THEREFORE, NO RETURN SAMPLE ANALYSIS COULD BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. 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, THE INSTRUMENT GAVE A NEGATIVE RESULT HOWEVER THE CUSTOMER SAW LINES AND QUESTIONED THIS RESULT. THE TEST WAS REPEATED ON ANOTHER ANALYZER WITH A NEW CARTRIDGE AND WAS ALSO RECEIVED A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.