BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DONORSCREEN-HLA CLASS I AND CLASS II ASSAY

    MDR report key: 4036658 · Received August 15, 2014

    Report

    Report Number
    2183608-2014-00006
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    November 8, 2013
    Report Date
    December 4, 2013
    Manufacturer
    IMMUCOR GIT DIAGNOSTICS, INC.
    Product Code
    MZI
    PMA / PMN Number
    BK070045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED (B)(4), WHERE CUSTOMER REPORTED TESTING A BATCH OF SAMPLES AND MORE THAN 90 PERCENT OF THE SAMPLES TESTED POSITIVE. SAMPLES WERE RE-TESTED, FOR A TOTAL OF 3 TIMES (TWICE, WITH SAME SHIPMENT AND ONCE WITH A NEW SHIPMENT OF DONORSCREEN-HLA ASSAY, LOT 300773A). ALL THREE TESTS GAVE THE SAME RESULT, OR MORE THAN 90 PERCENT SAMPLES TESTED POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490988 DONORSCREEN-HLA CLASS I AND CLASS II ASSAY DONORSCREN-HLA CLASS I AND CLASS II MZI IMMUCOR GIT DIAGNOSTICS, INC. NA 3000773A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA