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

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, FALSE POSITIVE FLU RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE OBTAINED. UPON PERFORMING CONFIRMATORY TESTING USING A MOLECULAR METHOD, NEGATIVE FLU RESULTS WERE OBTAINED. 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. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN UPDATED WITH ADDITIONAL INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, FALSE POSITIVE FLU B RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE OBTAINED. UPON PERFORMING CONFIRMATORY TESTING USING A MOLECULAR METHOD, NEGATIVE FLU B RESULTS WERE OBTAINED. THE ERRONEOUS RESULTS WERE COMMUNICATED TO THE CLINICIAN; HOWEVER, THERE WAS NO HEALTH IMPACT OR CLINICAL CONSEQUENCES REPORTED. 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 3039579. THE CUSTOMER REPORTED THAT THEY ARE RECEIVING A HIGH NUMBER OF FALSE POSITIVE RESULTS USING THE VERITOR KIT. CONFIRMATORY TESTING WAS PERFORMED AND ALL THE RESULTS CAME BACK NEGATIVE. 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 OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. 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, FALSE POSITIVE FLU B RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE OBTAINED. UPON PERFORMING CONFIRMATORY TESTING USING A MOLECULAR METHOD, NEGATIVE FLU B RESULTS WERE OBTAINED. THE ERRONEOUS RESULTS WERE COMMUNICATED TO THE CLINICIAN; HOWEVER, THERE WAS NO HEALTH IMPACT OR CLINICAL CONSEQUENCES REPORTED.