BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-LGG CARD

    MDR report key: 624907 · Received July 14, 2005

    Report

    Report Number
    1056600-2005-00065
    Event Type
    Malfunction
    Date Received
    July 14, 2005
    Date of Event
    April 15, 2005
    Report Date
    July 13, 2005
    Manufacturer
    MICRO TYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER IS CONCERNED THAT PERHAPS THE PROVUE IS MISSING WEAK REACTIONS IN ANTIBODY SCREENS WITH MTS ANTI-LGG CARD LOT # 110504001-24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ANTI-LGG CARD ANTIBODY SCREENING REAGENT KSZ MICRO TYPING SYSTEMS * 110504001-24

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other