BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ABD/ABD MONOCLONAL BLOOD GROUPING CARD

    MDR report key: 2193626 · Received August 5, 2011

    Report

    Report Number
    1056600-2011-00071
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED A BATCH RECORD REVIEW AND RETAINED TESTING. SATISFACTORY RESULTS WERE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING DONOR RETYPE TESTING IN MANUAL GEL, A GROUP O+ DONOR UNIT TYPED AS GROUP B+. THE ANTI B MICROWELL REACTED 1+. 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 113010053-14

    Patients

    Seq Age Sex Outcome Treatment
    1