BEUDAMED
    FDA Adverse Event Other Summary report: N

    ID-MTS ANTI-IGG CARD

    MDR report key: 552875 · Received April 23, 2004

    Report

    Report Number
    1056600-2004-00005
    Event Type
    Other
    Date Received
    April 23, 2004
    Date of Event
    March 25, 2004
    Report Date
    April 21, 2004
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PROVUE INSTRUMENT, BEING RUN WITH ORTHO 0.8% RESOLVE PANEL B RED CELLS AND MTS ANTI-IGC CARD, REPORTED FALSE NEGATIVE ON A PANEL FOR ANTI-JKA FOR PT PREVIOUSLY IDENTIFIED WITH ANTI-JKA AND ANTI-KELL. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ID-MTS ANTI-IGG CARD ANTIBODY SCREENING REAGENT KSZ MICRO TYPING SYSTEMS, INC. * 082203001-12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA