BEUDAMED
    FDA Adverse Event Other Summary report: N

    MTS BUFFERED GEL CARD

    MDR report key: 821680 · Received February 12, 2007

    Report

    Report Number
    1056600-2007-00042
    Event Type
    Other
    Date Received
    February 12, 2007
    Date of Event
    January 15, 2007
    Report Date
    February 12, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MTS BUFFERED GEL CARDS ARE NOT INTENDED FOR USE WITH INDIRECT ANTIGLOBULIN TESTING. THE USER SELF-IDENTIFIED THE ISSUE, CONTACTED OCD AND ALL TESTING WAS REPEATED. A DEFINITIVE ROOT CAUSE WAS DETERMINED. INCIDENT OCCURRED AS A RESULT OF USER ERROR. PRODUCT LABELING CLEARLY INDICATES WHICH TESTS ARE APPROPRIATE FOR USE WITH MTS BUFFERED GEL CARDS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY INADVERTENTLY PERFORMED INDIRECT ANTIGLOBULIN TESTING ON 40 PATIENT SAMPLES WITH MTS BUFFERED GEL CARDS INSTEAD OF ANTI-IGG CARDS. UPON INSTRUCTION FROM OCD; THE CUSTOMER RE-TESTED ALL OF THE PATIENT SAMPLES WITH MTS ANT-IGG GEL CARDS. THE CUSTOMER REPORTED THAT ONE OF THE 40 PATIENT SAMPLES REACTED POSITIVE FOR ANTIBODY UPON RE-TEST. THE CUSTOMER STATED NO TRANSFUSION REACTIONS WERE REPORTED AND AT THIS POINT, THEY WERE UNSURE IF ANY PATIENT HAD RECEIVED A TRANSFUSION. PRODUCT LABELING CLEARLY INDICATES THAT MTS BUFFERED GEL CARDS ARE INTENDED FOR USE WITH THE A/B/O SERUM GROUPING AS WELL AS DIRECT AGGLUTINATION I.E. COLD AND WARM ANTIBODY DETECTION WITH ENZYME TREATED CELLS. MTS BUFFERED GEL CARDS ARE NOT INTENDED FOR USE WITH INDIRECT ANTIGLOBULIN TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS BUFFERED GEL CARD ABO GROUP - RBC KSZ MICRO TYPING SYSTEMS, INC. NA 042406004-02

    Patients

    Seq Age Sex Outcome Treatment
    1 *