BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR +

    MDR report key: 10573201 · Received September 22, 2020

    Report

    Report Number
    MW5096798
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BD
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BD VERITOR + EMPLOYEE TESTED POSITIVE, WAS NEGATIVE ON F/U PCR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035784 BD VERITOR + CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP BD 020677

    Patients

    Seq Age Sex Outcome Treatment
    1 Other