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

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE VERITOR ANALYZER PROVIDED NEGATIVE FLU RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. HOWEVER, THE USER VISUALLY OBSERVED A LINE ON THE TEST CARTRIDGES AND QUESTIONED THE NEGATIVE RESULTS EXPECTING POSITIVE RESULTS. IN ADDITION TO VISUALLY READING THE TEST CARTRIDGES, THE USER WOULD REINSERT THE SAME NEGATIVE TEST CARTRIDGES BACK INTO THE VERITOR ANALYZER OR WAIT TWO MINUTES BEFORE REINSERTING AND OBTAIN POSITIVE FLU RESULTS FROM THE VERITOR ANALYZER. IT WAS NOTED THESE ACTIONS WERE CONSIDERED OFF-LABEL USE OF THE PRODUCT. THE USER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B AND NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER AFTER SEVERAL FOLLOW UP ATTEMPTS BY BD. IF A PATIENT AGREED TO HAVE CONFIRMATORY TESTING PERFORMED, PCR ON THE CEPHEID PLATFORM WAS USED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA/510(K)#: K132259, K132692, K151291, K152870, K160161. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY- THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER UNKNOWN. THE CUSTOMER REPORTED THAT SOME USERS WOULD SEE A LINE ON THE TEST CARTRIDGE, ASSUMING THE RESULT WOULD BE POSITIVE, BUT WHEN INSERTED INTO THE ANALYZER, IT WOULD PROVIDE A NEGATIVE RESULT. THEY REPORTED THAT THE USERS WOULD REMOVE THE CARTRIDGE AFTER THE NEGATIVE RESULT, RE-INSERT IT INTO THE ANALYZER OR WAIT 2 MINUTES BEFORE REINSERTING, WHICH THEN WOULD PROVIDE A POSITIVE 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 NOT PERFORMED AS THERE WAS NO BATCH NUMBER PROVIDED. NO PHOTOS OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. IT IS ADVISED THAT ALL TESTS MUST BE READ WITH AN ANALYZER, AND IF A RETEST IS DESIRED, TO USE A NEW TEST CARTRIDGE. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE VERITOR ANALYZER PROVIDED NEGATIVE FLU RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. HOWEVER, THE USER VISUALLY OBSERVED A LINE ON THE TEST CARTRIDGES AND QUESTIONED THE NEGATIVE RESULTS EXPECTING POSITIVE RESULTS. IN ADDITION TO VISUALLY READING THE TEST CARTRIDGES, THE USER WOULD REINSERT THE SAME NEGATIVE TEST CARTRIDGES BACK INTO THE VERITOR ANALYZER OR WAIT TWO MINUTES BEFORE REINSERTING AND OBTAIN POSITIVE FLU RESULTS FROM THE VERITOR ANALYZER. IT WAS NOTED THESE ACTIONS WERE CONSIDERED OFF-LABEL USE OF THE PRODUCT. THE USER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B AND NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER AFTER SEVERAL FOLLOW UP ATTEMPTS BY BD. IF A PATIENT AGREED TO HAVE CONFIRMATORY TESTING PERFORMED, PCR ON THE CEPHEID PLATFORM WAS USED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.