BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BDMAX SARS-COV-2 REAGENTS

    MDR report key: 10181834 · Received June 22, 2020

    Report

    Report Number
    1119779-2020-00160
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION (B)(4) WAS COMPLETED ON 2020-07-08. IT CONCERNED A HIGH RATE OF POSITIVE RESULTS WHEN USING THE BD SARS-COV-2 ASSAY. ACCORDING TO THE CUSTOMER, THE POSITIVE RESULTS HAD A LOW LEVEL OF FLUORESCENCE (BELOW 250) AND HIGH CT (ABOVE 30) FOR THE N2 TARGET, AND FLUORESCENCE CURVES ARE IRREGULAR AND LOOK LIKE BACKGROUND. IT CONSISTED IN VERIFICATION OF THE COMPLAINTS HISTORY, CUSTOMER DATA, AS WELL AS MANUFACTURING RECORDS OF THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0091427 AND BD SARS-COV-2 REAGENTS KIT LOT 0112228. MOREOVER, RETAIN MATERIAL FROM THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0091427 AND BD SARS-COV-2 REAGENTS KIT LOT 0112228 WERE TESTED. THE COMPLAINTS HISTORY SHOWED NO OTHER COMPLAINT ON THE BD MAX¿ EXK¿ TNA-3 LOT 0091427 NOR ON THE BD SARS-COV-2 REAGENTS KIT LOT 0112228. IN THE LAST TWELVE MONTHS, 21 OTHER COMPLAINTS WERE RECEIVED WITH THE BD MAX¿ EXK¿ TNA-3, AND 28 OTHER WITH THE BD SARS COV-2 REAGENTS, CONCERNING A SIMILAR ISSUE (FALSE POSITIVE OR DISCREPANT RESULT), WITH VARIOUS POTENTIAL CAUSES INCLUDING LOD OF PARTNER OR ALTERNATIVE METHOD, CONTAMINATION, COMPONENT- URS TIPS AND INSTRUMENT. MANUFACTURING AND QC DATA SHOWED THAT THE BD MAX¿ EXK¿ TNA-3 LOT 0091427, AS WELL AS BD SARS-COV-2 LOT 0112228, WERE WITHIN SPECIFICATIONS, MET THE QC CRITERIA FOR RELEASE AND USE, AND WITHIN THE TRENDS FOR THE LAST TWELVE MONTHS. MOREOVER, RETAIN MATERIAL TESTING FROM THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0091427 AND BD SARS-COV-2 REAGENTS KIT LOT 0112228 (COMBINATION USED BY THE CUSTOMER) GAVE EXPECTED NEGATIVE RESULTS. THE REAGENTS STILL PERFORM AS EXPECTED AND WERE NOT SUSPECTED OF BEING INVOLVED IN THE CUSTOMER ISSUE. ONE RUN WAS PROVIDED FOR THE ANALYSIS. RUN 1067, HAD ONE POSITIVE RESULT, AND THE CURVES ANALYSIS SHOWED A TRUE POSITIVE SAMPLE, AT THE LIMIT OF DETECTION (LOD) OF THE ASSAY. INDEED, A LATE POSITIVE RESULT WAS OBTAINED FOR THE N2 TARGET, WITH A CT OF 34,5 AND AN EP OF 741, WHICH PASSED THE EP DYNAMIC THRESHOLD TO BE CALLED POSITIVE BY THE ALGORITHM. ANALYSIS OF THE CURVES IN RAW RAW REVEALED NO ANOMALY AND CONFIRMED THAT THE SAMPLE WAS A TRUE POSITIVE. NO ANOMALY IN CT VALUES AND LEVEL OF FLUORESCENCE WAS OBSERVED IN THE CURVES, CONTRARY TO WHAT WAS MENTIONED BY THE CUSTOMER. OVERALL, THE RESULTS OBTAINED SHOWED THAT THE POSITIVE RESULT OBTAINED ON RUN 1067 WAS A TRUE BD SARS COV-2 POSITIVE SAMPLE. THE REAGENTS WERE NOT SUSPECTED OF BEING INVOLVED IN THE CUSTOMER ISSUE. UPDATE RISK MANAGEMENT FILE: THERE IS NO NEED TO UPDATE THE REAGENT RISK MANAGEMENT FILE SINCE IT IS ALREADY COVERED IN THE PACKAGE INSERT OF THE ASSAY. MOREOVER, POTENTIAL CAUSE SUCH AS LIMIT OF DETECTION HAVE ALREADY BEEN IDENTIFIED AND DOCUMENTED INTO THE RISK MANAGEMENT FILE DOCUMENT (B)(4). CURRENT RISK ASSESSMENT REMAINS RELEVANT. THE ROOT CAUSE FOR THE DISCREPANT RESULT WAS NOT IDENTIFIED HOWEVER THE MOST PROBABLE CAUSE IS SAMPLE AT THE LIMIT OF DETECTION OF THE BD MAX SARS-COV-2 REAGENTS KIT. THE BD MAX SARS-COV-2 REAGENTS KIT IS NOT SUSPECTED OF BEING THE CAUSE. THERE IS NO COMPLAINT TREND FOR DISCREPANT RESULT FOR THE BD MAX SARS-COV-2 REAGENTS KIT LOT 0112228. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. THE FALSE RESULTS WERE NOT REPORTED TO THE CLINICIANS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. THE FALSE RESULTS WERE NOT REPORTED TO THE CLINICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641410 KIT BDMAX SARS-COV-2 REAGENTS SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0112228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other