BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 3004038 · Received March 14, 2013

    Report

    Report Number
    1056600-2013-00007
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED TESTING, BATCH RECORD REVIEW, AND COMPLAINT REVIEW WERE PERFORMED. RESULTS OF INVESTIGATION WERE SATISFACTORY. THERE WERE NO OTHER COMPLAINTS AGAINST THIS LOT OF PRODUCT. THIS APPEARS TO BE ISOLATED TO THIS ONE CUSTOMER SITE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DISCREPANT RESULT WHEN TESTING A DONOR UNIT. A UNIT LABELED AS A POS WAS RETYPED AS AN AB POS. TESTING WAS PERFORMED IN MANUAL GEL. THE UNIT WAS RETURNED TO THE (B)(6). DURING TROUBLESHOOTING IT WAS DETERMINED THAT CUSTOMER'S TEST PROTOCOL UTILIZED MTS DILUENT 2 AND A 0.8% CELL SUSPENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107853 MTS A/B/D MONOCLONAL GROUPING CARD BLOOD GROUPING REAGENT KSZ MICROTYPING SYSTEMS 121012053-01

    Patients

    Seq Age Sex Outcome Treatment
    1