BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTIGEN FLU-A

    MDR report key: 59768 · Received January 2, 1997

    Report

    Report Number
    MW1010499
    Event Type
    Malfunction
    Date Received
    January 2, 1997
    Report Date
    January 2, 1997
    Manufacturer
    BECTON DICKINSON MICROBIOLGY SYSTEMS
    Product Code
    GNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WERE FIVE INSTANCES IN WHICH THE DIAGNOSTIC TESTS TESTED NEGATIVE; ALTHOUGH WHEN CULTURED, ALL (5) TESTED POSITIVE FOR THE INFLUENZA A VIRUS. EVENT DATE: WITHIN LAST 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECTIGEN FLU-A DIAGNOSTIC TEST FOR INFLUENZA A VIRUS GNT BECTON DICKINSON MICROBIOLGY SYSTEMS NA 38004562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA