BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM

Description of Event or Problem

REPORT 5 OF 6: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, THERE WERE FALSE POSITIVES. RUN 2113: B3: POSITIVE FOR FLU A. SPECIMENS WERE NOT REPEATED. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

H3. 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 5 OF 6: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, THERE WERE FALSE POSITIVES. RUN 2113 - B3, POSITIVE FOR FLU A. SPECIMENS WERE NOT REPEATED. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ RESPIRATORY VIRAL PANEL ASSAY (REF. 445373) FROM LOT 3237371 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT SIX POSITIVE RESULTS WHEN USING THE BD MAX¿ RESPIRATORY VIRAL PANEL KIT LOT 3237371 THAT COULD NOT BE REPRODUCED USING QUIDEL (FLU AND RSV) OR BIORAD (COVID) PLATFORMS. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ RESPIRATORY VIRAL PANEL ASSAY INDICATED THAT LOT 3237371 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED SAMPLE RUNS 2111, 2113 AND ENVIRONMENTAL RUN 2116 FROM INSTRUMENT CT1490 THAT WERE ANALYZED. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS SAMPLES IDENTIFIED BY THE COSTUMER FOUND IN RUN 2111; POSITION A3 AND RUN 2113; POSITION. ALL GAVE A LOW BUT TRUE AMPLIFICATION. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. ENVIRONMENTAL RUN (RUN 2116) SHOWED THAT 5 SAMPLES WERE TESTED AND ONE OF THEM GAVE A COV-2 POSITIVE RESULT, SUGGESTING ENVIRONMENTAL CONTAMINATION AT THE CUSTOMER SITE. THE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ RESPIRATORY VIRAL PANEL ASSAY LOT 3237371. 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. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.