BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

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)#: K121797;K132256;K132693;K133138;K151301;K152874;K160164. 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 WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. 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. THIS IS REPORT 7 OF 10.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY - THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL#: 256041), BATCH NUMBER UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED FALSE POSITIVE RESULTS WITH 10 PATIENT SAMPLES; THEY REPORTED INITIALLY RECEIVING A POSITIVE RESULT, THEN A NEGATIVE RESULT WHEN REPEATING THE TEST WITH A NEW CARTRIDGE. THEY ALSO PERFORMED CONFIRMATORY MOLECULAR TESTING ON THE PATIENT SAMPLES. 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. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS FOR FALSE POSITIVE. 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 LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. 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. THIS IS REPORT 7 OF 10.