BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-IGG CARD

    MDR report key: 789095 · Received November 22, 2006

    Report

    Report Number
    1056600-2006-00340
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    October 25, 2006
    Report Date
    November 22, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    MALFUNCTION OF THE INDIVIDUAL GEL CARDS USED FOR THE RELEVANT TESTS, ALBEIT UNLIKELY, CANNOT BE RULED OUT WITH ABSOLUTE CERTAINTY. IN THIS CASE, THE PRESENCE OF THE ANTI-E ANTIBODY WAS IDENTIFIED IN THE PT SAMPLE UPON REPEAT TESTING, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED OUTSIDE OF THE LAB. THE PT WAS TRANSFUSED WITH COMPATIBLE BLOOD AND NO DEATH OR SERIOUS INJURY WAS REPORTED. HOWEVER, IF AN INCIDENT OF THIS NATURE WERE TO RECUR UNDETECTED, A FALSE NEGATIVE REACTION IN INDIRECT ANTIGLOBULIN TESTS MAY LEAD TO THE TRANSFUSION OF INCOMPATIBLE BLOOD. STN# 103461.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY PERFORMED ANTIBODY SCREEN TESTING WITH THE MTS ANTI-IGG GEL CARD LOT# 042406001-22 AND OBSERVED FALSE NEGATIVE REACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ANTI-IGG CARD AUTOMATED BLOOD GROUPING AND ANTIBODY TE KSZ MICRO TYPING SYSTEMS, INC. * 042406001-22

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR