BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ABD/ABD MONOCLONAL BLOOD GROUPING CARD

    MDR report key: 2193075 · Received August 5, 2011

    Report

    Report Number
    1056600-2011-00069
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED A BATCH RECORD REVIEW. SATISFACTORY RESULTS WERE OBSERVED. CUSTOMER REPORTED THAT UPON TROUBLESHOOTING, LOW LIQUID LEVELS WERE OBSERVED IN SOME OF THE CARDS. CUSTOMER WAS INSTRUCTED TO INSPECT CARDS PRIOR TO USE AS INSTRUCTED IN THE IFU. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING DONOR RETYPE TESTING IN MANUAL GEL, A GROUP A+ DONOR UNIT TYPED AS AB+. THE ANTI A MICROWELL REACTED 4+ AND THE B MICROWELL REACTED 3+. THE CUSTOMER REPEATED THE TESTING AFTER WASHING THE CELLS 3 TIMES WITH SALINE AND MAKING THE APPROPRIATE CELL SUSPENSION. A 2+ REACTION WAS NOTED WITH THE ANTI B MICROWELL. NO ERRONEOUS RESULTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ABD/ABD MONOCLONAL BLOOD GROUPING CARD BLOOD GROUPING REAGENT KSZ MICROTYPING SYSTEMS 092010053-07

    Patients

    Seq Age Sex Outcome Treatment
    1