BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 1230495 · Received November 7, 2008

    Report

    Report Number
    1056600-2008-00345
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 7, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED 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 THREE CORD SAMPLES REACTED AS FALSE POSITIVES IN THE ANTI-B MICROTUBES OF THE MTS ABD MONOCLONAL GROUPING CARD LOT# 121707053-11. THE CUSTOMER REPEATED THE SAMPLES USING TUBE METHOD AND OBTAINED NEGATIVE REACTIONS WITH ANTI-B ANTISERA. NO ERRONEOUS RESULTS WERE REPORTED. FALSE POSITIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD. THE CUSTOMER ISSUE IS ALSO BEING REPORTED UNDER MEDWATCH MFR #S 1056600-2008-00343 AND 1056600-2008-00345, TO DOCUMENT ADDITIONAL FALSE POSITIVE RESULTS INDICATED BY THE CUSTOMER IN THE COMPLAINT FROM THE SAME LOT OF GEL CARDS.

    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 121707053-11

    Patients

    Seq Age Sex Outcome Treatment
    1