BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 1232740 · Received November 14, 2008

    Report

    Report Number
    1056600-2008-00346
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 14, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED AND RETURNED TESTING PERFORMED AT MTS USING THE RETURNED SAMPLES (TWO CORD SAMPLES) WAS SATISFACTORY. RESULTS WERE NEGATIVE IN THE ANTI-B MICROTUBES. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. NO DEFINITIVE ROOT CAUSE WAS DETERMINED FOR THE FALSE POSITIVE REACTIONS OBTAINED AT THE CUSTOMER SITE. GEL CARDS PERFORMED AS EXPECTED AT THE OCD SITE AND NO DISCREPANCIES OR FALSE POSITIVE REACTIVITY WERE OBSERVED IN ANY OF THE GEL CARDS. BATCH RECORD REVIEW WAS WITHIN RELEASE SPECIFICATIONS. INCIDENT IS ISOLATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SAMPLE REACTED AS FALSE POSITIVE IN THE ANTI-B MICROTUBE OF THE MTS ABD MONOCLONAL GROUPING CARD LOT# 061708053-01. NO ERRONEOUS RESULTS WERE REPORTED. FALSE POSITIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS A/B/D MONOCLONAL GROUPING CARD A/B/O & RH TYPE TESTING REAGENT KSZ MICRO TYPING SYSTEMS, INC. NA 061708053-01

    Patients

    Seq Age Sex Outcome Treatment
    1