BD VERITOR¿ PLUS ANALYZER

Additional Manufacturer Narrative

THE REQUESTED 510K INFORMATION FOR THE INVOLVED VERITOR ASSAY IS AS FOLLOWS: G4. PMA/510(K)#: EUA (B)(4). 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

REPORT 1 OF 4. IT WAS REPORTED WHILE USING THE BD VERITOR¿ PLUS ANALYZER, A NEGATIVE SARS COVID RESULT FOR ONE (1) PATIENT SAMPLE WAS OBTAINED. HOWEVER, THE USER VISUALLY OBSERVED LINES ON THE TEST CARTRIDGE AND QUESTIONED THE NEGATIVE RESULT INTERPRETING THE LINES AS A POSITIVE RESULT. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY - THE COMPLAINT ALLEGES THE BD VERITOR PLUS ANALYZER HAD A DISCREPANT RESULTS ISSUE (CATALOG NUMBER 256066, SERIAL NUMBER (B)(6)). THE CUSTOMER REPORTED THAT VERITOR COVID TEST CARTRIDGES SHOWED POSITIVE LINES VISUALLY, BUT THE ANALYZER DISPLAYED NEGATIVE RESULTS. THE ISSUE OCCURRED ONLY WITH COVID TEST KITS; OTHER TEST KITS FUNCTIONED NORMALLY. INITIALLY, A VERIFICATION CARTRIDGE WAS PLANNED TO BE SENT, BUT THIS WAS NOT DONE AFTER CONFIRMING THAT OTHER TESTS WERE WORKING PROPERLY. IT WAS DETERMINED THAT THE CUSTOMER HAD BEEN INCUBATING THE COVID TEST CARTRIDGES FOR ONLY 10 MINUTES. THE CUSTOMER WAS INFORMED THAT, PER THE INSTRUCTIONS FOR USE (IFU), INCUBATION MUST BE 15 MINUTES AND NO LONGER THAN 20 MINUTES BEFORE INSERTING THE CARTRIDGE INTO THE ANALYZER. THE CUSTOMER AGREED TO FOLLOW THE CORRECT INCUBATION INSTRUCTIONS AND MONITOR WHETHER THE ISSUE REOCCURS. THIS IS NOT TRUE INSTRUMENT FAILURE, THUS THE COMPLAINT IS NOT CONFIRMED. DEVICE HISTORY RECORD REVIEW FOR VERITOR PLUS ANALYZER, SERIAL NUMBER (B)(6) WAS REVIEWED AND NONCONFORMANCES RELATED TO THIS FAILURE MODE WERE NOT REVEALED IN MANUFACTURING DURING FINAL TESTING. THE DEVICE WAS RELEASED CONFORMING. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT.

Description of Event or Problem

REPORT 1 OF 4. IT WAS REPORTED WHILE USING THE BD VERITOR¿ PLUS ANALYZER, A NEGATIVE SARS COVID RESULT FOR ONE (1) PATIENT SAMPLE WAS OBTAINED. HOWEVER, THE USER VISUALLY OBSERVED LINES ON THE TEST CARTRIDGE AND QUESTIONED THE NEGATIVE RESULT INTERPRETING THE LINES AS A POSITIVE RESULT. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.