BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10278564 · Received July 15, 2020

    Report

    Report Number
    1119779-2020-00221
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 24, 2020
    Report Date
    September 17, 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 · 0

    INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAXTM SYSTEM (REF# 445003) LOT 0100384 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE QC RESULTS WERE COMPLIANT. CUSTOMER SENT FOUR PICTURES OF CURVES THAT SEEM TO REPRESENT ONE SAMPLE, HOWEVER NO IDENTIFICATION OR STATUS RESULTS WERE PROVIDED. NONETHELESS, A N1 POSITIVE RESULT IS PRESUMED, WITH AN ATYPICAL CURVE LOOKING LIKE A GLITCH, WHICH GENERATED A CT SCORE AND CONSEQUENTLY A POSITIVE STATUS. THIS CURVE DOES NOT SEEM LIKE TRUE AMPLIFICATION. HOWEVER, WITHOUT THE RUN DATA, IT IS DIFFICULT TO ANALYZE THE RESULTS THOROUGHLY. BD HAS RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR WEAK N1 POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM. MOST OF THESE COMPLAINTS CONCERNED ATYPICAL CURVES, WITH LOW ENDPOINTS. ANALYSIS OF THE VARIOUS DATABASES RECEIVED FROM CUSTOMERS REVEALED EVIDENCE OF SIMILAR PATTERNS. ALL THE RUNS ANALYZED SHOWED PRESENCE OF BACKGROUND NOISE CAUSED BY SIGNAL DRIFT IN THE CY5 CHANNEL, WITH THE N1 TARGET CAUSING AN INTERRUPTION IN BACKGROUND CORRECTION, GENERATING A STEADY INCREASE OF FLUORESCENCE IN THE CURVES, RESULTING IN FALSE POSITIVE RESULTS. IN ALL CASES, CONTRIBUTING FACTORS INCLUDED PRODUCT DESIGN. COMPLAINT VERIFICATION SHOWED A COMPLAINT TREND ON BD SARS-COV-2 REAGENTS FOR BD MAXTM SYSTEM LOTS FOR FALSE POSITIVE RESULTS. THE ROOT CAUSE IS UNDER INVESTIGATION AND WILL BE DOCUMENTED IN OUR QUALITY SYSTEM. BD CONFIRMS THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED.

    Description of Event or Problem · 0

    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. THERE WAS NO REPORT OF PATIENT IMPACT.

    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).

    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. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739058 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0100384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other