BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2

    MDR report key: 10656689 · Received October 8, 2020

    Report

    Report Number
    MW5097154
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 7, 2020
    Manufacturer
    BD
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    EIGHT (8) FALSE POSITIVE RESULTS FROM BD VERITOR SYSTEM ANALYZER MACHINE WITH TEST STRIPS FROM LOT # 0212777; 8 FALSE POSITIVE RESULTS RETURNED NEGATIVE WITH PCR TESTING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118156 BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 0212777
    1118158 BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 0212777
    1118159 BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 0212777
    1118160 BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 0212777
    1118165 BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 0212777
    1118166 BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 0212777
    1118167 BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 0212777
    1118168 BD VERITOR PLUS ANALYZER SYSTEM FOR SARS/COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 0212777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other