KIT FLU A+B 30 TEST HOSPITAL VERITOR

Additional Manufacturer Narrative

THERE WERE MULTIPLE PMA/510K NUMBERS. THE INFORMATION FOR EACH ADDITIONAL PMA/510K IS AS FOLLOWS: G.5. PMA / 510(K)#: K132259, K132692, K151291, K152870, K160161 K121797, K132256, K132693, K133138, K151301, K152874, K160164 H.3. 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 IS REPORTED THAT DURING USE OF THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THREE 3 LINES APPEARED ON TEST CARTRIDGE: CONTROL, FLU A, AND LINE BELOW FLU A. TEST WAS READ ON VERITOR AND FLU A POSITIVE WAS THE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES ERRONEOUS RESULT WHEN USING BD VERITOR¿ FLU A+B KIT (MATERIAL#: 256041), BATCH NUMBER 3035676. THE CUSTOMER REPORTED THAT THEY VISUALLY SAW 3 LINES ON THE TEST CARTRIDGE, CONTROL LINE, FLU A, AND ANOTHER LINE UNDER FLU A, BUT WHEN READ ON THE VERITOR ANALYZER, THE RESULT WAS FLU A POSITIVE. THEY REPORTED NOT TRUSTING THE RESULT. 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 SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, A PHOTOGRAPH WAS RETURNED THAT SHOWED 3 LINES ON THE TEST CARTRIDGE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR ERRONEOUS RESULT WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THE CUSTOMER WAS INFORMED THAT TEST CARTRIDGES SHOULD NOT BE READ VISUALLY AND TO ALWAYS USE THE ANALYZER TO RECEIVE RESULTS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

Description of Event or Problem

IT IS REPORTED THAT DURING USE OF THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THREE 3 LINES APPEARED ON TEST CARTRIDGE: CONTROL, FLU A, AND LINE BELOW FLU A. TEST WAS READ ON VERITOR AND FLU A POSITIVE WAS THE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.