BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    MDR report key: 10897465 · Received November 24, 2020

    Report

    Report Number
    1119779-2020-01078
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 27, 2020
    Report Date
    August 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR FALSE POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. THE CURRENT INVESTIGATION CONCERNS MULTIPLE LOTS OF BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES (IF APPLICABLE). THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. FUNCTIONAL ANALYSIS OF RETENTION MATERIALS MET ACCEPTANCE CRITERIA. NO RETURNS WERE RECEIVED TO INVESTIGATE. QUALITY WAS UNABLE TO DUPLICATE THE CUSTOMERS REPORTED FAILURE MODE. COMPLAINT TRENDING REVIEW REVEALS A TREND IN CUSTOMER COMPLAINTS RELATED TO FALSE POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. ALTHOUGH THE INVESTIGATION WAS NOT CONFIRMED, BASED ON THE COMPLAINT TREND, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED (1878253) TO DETERMINE ROOT CAUSE(S). BD POINT OF CARE WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH FALSE POSITIVE OR DISCREPANT RESULTS WHEN USING THE KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 THREE FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE NEGATIVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER AT THIS TIME. EUA#: (B)(4)

    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). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0216765. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0220584. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 THREE FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE NEGATIVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER AT THIS TIME. EUA#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356256 BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1