BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-IGG CARD

    MDR report key: 714801 · Received August 19, 2005

    Report

    Report Number
    1056600-2005-00077
    Event Type
    Malfunction
    Date Received
    August 19, 2005
    Date of Event
    July 18, 2005
    Report Date
    August 17, 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 REPORTS THAT 2 PT WITH A PREVIOUS HISTORY OF ANTI-E AND ONE PT WITH A PREVIOUS HISTORY OF ANTI-JKA FAILED TO REACT WITH MTS ANTI-LGG LOT# 122204001-18 AND 3% SURGISCREEN LOT# 3SS301.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ANTI-IGG CARD ANTIBODY SCREENING REAGENT KSZ MICRO TYPING SYSTEMS * 122204001-18

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other