BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 12633027 · Received October 14, 2021

    Report

    Report Number
    1119779-2021-01649
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 23, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT (REF (B)(4) LOT 1120394 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INDICATED THAT LOT 1120394 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT ONE SAMPLE THAT GAVE FALSE POSITIVE RESULT WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 1120394 BUT WAS NEGATIVE WITH THE GENEXPERT ASSAY. CUSTOMER PROVIDED ONE RUN #723 FROM INSTRUMENT CT1590 FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INSTRUCTION FOR USE. RUN 723 CONTAINED 24 SAMPLES, AND ALL OBTAINED A NEGATIVE RESULT EXCEPT SAMPLE IN POSITION B07, WHICH GAVE A POSITIVE RESULT FOR BOTH N1 AND N2 TARGETS. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ON THIS SAMPLE IN POSITION B7. CURVE ANALYSIS SHOW NO ANOMALY, WITH TRUE AMPLIFICATION OF BOTH N1 AND N2 TARGETS, WITH MODERATE CT VALUES OF 29.6 AND 30.9, RESPECTIVELY. THE DISCREPANT RESULT FOR THIS SAMPLE BETWEEN THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM AND THE GENEXPERT ASSAY, IS SUSPECTED OF BEING DUE TO DIFFERENT LIMIT OF DETECTION BETWEEN ASSAYS. IT MUST BE NOTED THAT THE GENEXPERT ASSAY ONLY DETECTS THE N2 AND E GENE TARGETS AND DOES NOT DETECT THE N1 TARGET. THEREFORE, WITH THIS ASSAY, THE CUSTOMER CANNOT CONFIRM THE N1 POSITIVE RESULTS OBTAINED WITH THE BD SARS-COV-2 REAGENT KIT. A CONTAMINATION ISSUE WHEN PREPARING THE SAMPLES IS ALSO A POSSIBLE ROOT CAUSE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES IS A CONSERVATIVE ASSESSMENT OF THE DATA. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S DISCREPANT RESULTS, HOWEVER BASED ON THE DATA ANALYZED, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM LOT 1120394. THE ROOT CAUSE WAS NOT IDENTIFIED. NOTE THAT POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY OR A THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE CAN EXPLAIN THE CUSTOMER DISCREPANT SAMPLES. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. SEE H.10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2, A FALSE POSITIVE RESULT FOR A HIGH CT VALUE WAS PRODUCED BY THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM. CONFIRMATORY TESTING WAS PERFORMED WITH THE GENEXPERT THAT PRODUCED NEGATIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#:(B)(4)THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HIGH CT VALUE POSITIVE, REPEAT GENEXPERT - NEGATIVE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2, A FALSE POSITIVE RESULT FOR A HIGH CT VALUE WAS PRODUCED BY THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM. CONFIRMATORY TESTING WAS PERFORMED WITH THE GENEXPERT THAT PRODUCED NEGATIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HIGH CT VALUE POSITIVE, REPEAT GENEXPERT - NEGATIVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529312 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1120394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown