BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VERITOR SYSTEM

    MDR report key: 10539982 · Received September 15, 2020

    Report

    Report Number
    MW5096645
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 11, 2020
    Manufacturer
    BECTON DICKINSON AND COMPANY / BD
    Product Code
    QKP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    TESTED POSITIVE FOR COVID 19 WITH THE USE OF OUR BD VERITOR ANTIGEN KIT. EMPLOYEE DID A FOLLOW UP PCR TEST AT HER CLINIC WITHIN 24 HOURS AND THE RESULT WAS NEGATIVE FOR COVID 19. BD VERITOR ANTIGEN KIT REF 256082, LOT#0220417, KIT #256066. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999782 BD VERITOR SYSTEM CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP BECTON DICKINSON AND COMPANY / BD

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other