BD MAX¿ RESPIRATORY VIRAL PANEL

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY (REF. (B)(4) LOT 5044778 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ RESPIRATORY VIRAL PANEL ASSAY INDICATED THAT LOT 5044778 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY (REF. (B)(4) LOT 5044778 WAS TESTED AND THE RESULTS WERE AS EXPECTED. THE CUSTOMER REPORTED DISCREPANCY WITH FLU A DETECTION SINCE THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM KIT LOT 5044778 YIELDED A FLU A NEGATIVE RESULT TWICE WHEREAS THE BIOFIRE FILMARRAY IDENTIFIED THE SAMPLE AS FLUA/H1 POSITIVE. ACCORDING TO THE CUSTOMER, AFTER THE EXTRACTION PROCESS USING THE BD MAX¿ RVP ASSAY, 5UL OF THE RESIDUAL ELUATE WAS USED TO PERFORM AN IN-HOUSE INFLUENZA TYPING TEST IN PCR ONLY, WHICH YIELDED AN H1 POSITIVE RESULT WITH A CT VALUE OF 33. TWO RUNS PERFORMED USING BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY WERE PROVIDED FOR INVESTIGATION (RUN #3424 AND #3427) AND WERE ANALYZED. MANUAL PCR CURVE ADJUDICATION SHOWED NO AMPLIFICATION IN THE CY5 CHANNEL (FLUA TARGET) IN EITHER RUN (A7; RUN 3424 AND B3; RUN 3427). FURTHER ANALYSIS REVEALED THAT THE INTERNAL CONTROL (RNASEP IN THE ROX CHANNEL) SHOWED AN AMPLIFICATION CURVE AS EXPECTED IN BOTH RUNS, INDICATING NO ISSUE WITH ASSAY PERFORMANCE. MOREOVER, ALTHOUGH AN ALTERNATIVE TESTING PLATFORM IDENTIFIED THE SAMPLE AS FLUA POSITIVE, LIMITS OF DETECTION CAN VARY BETWEEN ASSAYS / VERIFICATION METHODS, AND THIS MAY EXPLAIN THE DISCREPANCY OBSERVED BY THE CUSTOMER. THIS IS FURTHER SUPPORTED BY THE FACT THAT THE CUSTOMER¿S IN-HOUSE TYPING ASSAY YIELDED A POSITIVE RESULT, WITH A RELATIVELY LATE CT VALUE (33). SUCH LOW POSITIVE SAMPLES CAN OCCUR DUE TO WEAK VIRAL TITERS IN THE SPECIMEN. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY FROM LOT 5044778. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SAMPLE AT OR NEAR THE ASSAY LOD IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE NEGATIVE INFLUENZA A PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEAT TESTED AND REMAINED INFLUENZA A NEGATIVE. SAMPLE WAS THEN TESTED ON FILMARRAY, WHICH IDENTIFIED THE SAMPLE AS INFLUENZA A POSITIVE. INFLUENZA A TYPING LDT WAS ALSO PERFORMED ON RESIDUAL SAMPLE AND THE RESULT WAS INFLUENZA A POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

D.2. ADDITIONAL MEDICAL DEVICE TYPE: QQX. 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 THAT DURING USE OF BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE NEGATIVE INFLUENZA A PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEAT TESTED AND REMAINED INFLUENZA A NEGATIVE. SAMPLE WAS THEN TESTED ON FILMARRAY, WHICH IDENTIFIED THE SAMPLE AS INFLUENZA A POSITIVE. INFLUENZA A TYPING LDT WAS ALSO PERFORMED ON RESIDUAL SAMPLE AND THE RESULT WAS INFLUENZA A POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.