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

Additional Manufacturer Narrative

E.1 INITIAL REPORTER E-MAIL: (B)(6). INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULTS WHEN USING KIT RAPID DETECTION OF KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER 2333594. THE CUSTOMER REPORTED DISCREPANT RESULTS WITH FLU KIT AND NO FURTHER INFORMATION WAS PROVIDED. DURING A FOLLOW UP, THE CUSTOMER STATED THAT THE READINGS ARE ACCURATE AT THIS POINT. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE DISCREPANT RESULT 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. NO PHOTOS OR PHYSICAL SAMPLES WERE RECEIVED; THEREFORE, NO RETURN SAMPLE ANALYSIS COULD BE PERFORMED. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. CURRENTLY NO ADVERSE TREND IDENTIFIED FOR THE REPORTED ISSUE. 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, THERE WAS A DISCREPANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.