BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 1060815 · Received June 12, 2008

    Report

    Report Number
    1056600-2008-00199
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    OCD WAS UNABLE TO CONFIRM THE CUSTOMER'S COMPLAINT. RETAINED TESTING AND BATCH RECORD REVIEW WERE WITHIN RELEASE SPECIFICATIONS. THE CUSTOMER INDICATED THAT THEY WERE USING SAMPLES FROM NEONATES TO ADULTS PTS WITH VARYING IMMUNO-SUPPRESS DIAGNOSIS FOR TESTING. LABELING CAUTIONS THE USER THAT IN SOME PTS (E.G., NEWBORNS, ELDERLY OR IMMUNOCOMPROMISED PTS) THE EXPECTED ABO ANTIBODIES MAY BE WEAK OR MISSING. INCIDENT IS MOST LIKELY SAMPLE RELATED. DIFFERENCES OBSERVED BETWEEN TUBE AND GEL TEST METHODS ARE NOT UNCOMMON. INCIDENT IS ISOLATED. ADD'L COMPLAINTS WERE OPENED FOR LOT 121707037-03. OCD COMPLAINT MDR#1056600-2008-00200 AND LOT 101007037-14, OCD COMPLAINT MDR# 1056600-2008-00201.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED DISCREPANT RESULTS BETWEEN THE FORWARD AND REVERSE GROUPING USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT# 111307037-09. THE CUSTOMER REPEATED THE SAMPLES IN THE TUBE METHOD AND OBTAINED ACCEPTABLE RESULTS. THE CUSTOMER USED ALTERNATE LOTS OF GEL CARDS (101007037-14 AND 121707037-03) AND OBTAINED THE SAME DISCREPANT RESULTS WITH THE SAMPLES. ERRONEOUS RESULTS WERE NOT REPORTED. FALSE NEGATIVE 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 AND REVERSE GROUPING CARD A/B/O & RH TYPE TESTING REAGENT KSZ MICRO TYPING SYSTEMS, INC. NA 111307037-09

    Patients

    Seq Age Sex Outcome Treatment
    1