BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10353915 · Received July 31, 2020

    Report

    Report Number
    1119779-2020-00253
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 28, 2020
    Report Date
    October 12, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WHEN USING THE BDMAX SARS-COV-2 REAGENTS (REF# 445003) LOT 0121412 WAS PERFORMED BY THE VERIFICATION OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE QC RESULTS WERE COMPLIANT. CUSTOMER COMPLAINED OF A SUDDEN INCREASE OF SUSPECTED FALSE POSITIVE RESULTS WHEN USING THE BDMAX SARS-COV-2 ASSAY. CUSTOMER PROVIDED RUN #241 FOR INVESTIGATION. ANALYSIS CURVES OF SUSPECTED FALSE POSITIVE SAMPLES SHOW THAT THEY LOOK LIKE REAL BUT LATE AMPLIFICATION. MOREOVER, THE INTERNAL CONTROLS VALUES WERE COMPARABLE FROM SAMPLES TO SAMPLES. THE UDP PARAMETERS USED BY THE CUSTOMER HAVE BEEN COMPARED TO THE PACKAGE INSERT RECOMMENDATIONS AND IT WAS FOUND THAT THERE WAS NO COLOR COMPENSATION FOR THE CY5 CHANNEL (N2 TARGET). IT COULD EXPLAIN THE FALSE N2 POSITIVE RESULTS. BD PERFORMED ADDITIONAL TEST WITH A SET OF KNOW SAMPLES (FOUR POS AND FOR NEG) AND WAS COMPARED RESULTS OF CUSTOMER BD MAX (CT1481) WITH A DEMO BD MAX. NOTED THAT THE SAME REAGENTS WERE USED FOR THE TEST ON BOTH INSTRUMENTS. THE DEMO BD MAX GAVE THE EXPECTED RESULTS WHEREAS THE CUSTOMER BD MAX GAVE SEVEN POSITIVE AND ONE NEGATIVE RESULTS. THERE IS NO COMPLAINT TREND FOR FALSE POSITIVE RESULTS FOR THE BD MAX SARS-COV-2 REAGENT LOT 0121412. THE ROOT CAUSE FOR THE CUSTOMER ISSUE WAS IDENTIFIED AS INADEQUATE UDP PARAMETERS USED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (EUA200159) FALSE POSITIVE RESULTS WERE OBTAINED ON RUN 242.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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 ((B)(4)) FALSE POSITIVE RESULTS WERE OBTAINED ON RUN 242.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817371 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM DIAGNOSTIC STAINS AND REAGENTS QJR BECTON, DICKINSON & CO. 0121412

    Patients

    Seq Age Sex Outcome Treatment
    1 Other