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

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 3275828. THE CUSTOMER REPORTED THAT THEY RECEIVED TWO POSITIVE FLU B RESULTS FOR PATIENT SAMPLES, BUT WHEN RE-INSERTED RIGHT AWAY, THE RESULTS ARE NEGATIVE. THEY CONFIRMED THAT THEY TESTED THE SAME SAMPLES ON A MOLECULAR PLATFORM, AND RECEIVED FLU B NEGATIVE RESULTS. 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 PHOTOS WERE RECEIVED. IN ADDITION, NO SAMPLES WERE RECEIVED WITHIN 30 CALENDAR DAYS FROM COMPLAINT OPEN DATE; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE INVESTIGATION WILL BE CLOSED BASED ON THE INFORMATION AVAILABLE TO DATE. IF SAMPLES ARE RECEIVED LATER, THE COMPLAINT MAY BE REOPENED. 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) FLU B POSITIVE PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. IT WAS NOTED THE USER IMMEDIATELY RE-INSERTED THE SAME CARTRIDGE BACK INTO A VERITOR ANALYZER AND A FLU B NEGATIVE RESULT WAS OBTAINED. THE PATIENT SAMPLE WAS ALSO TESTED USING MOLECULAR PLATFORMS (LIAT ROCHE AND DIASORIAN), AND EACH PROVIDED A FLU B NEGATIVE RESULT. IT SHOULD BE NOTED THE ACTION OF REINSERTING A USED TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

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) FLU B POSITIVE PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. IT WAS NOTED THE USER IMMEDIATELY RE-INSERTED THE SAME CARTRIDGE BACK INTO A VERITOR ANALYZER AND A FLU B NEGATIVE RESULT WAS OBTAINED. THE PATIENT SAMPLE WAS ALSO TESTED USING MOLECULAR PLATFORMS (LIAT ROCHE AND DIASORIAN), AND EACH PROVIDED A FLU B NEGATIVE RESULT. IT SHOULD BE NOTED THE ACTION OF REINSERTING A USED TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.