BEUDAMED
    FDA Adverse Event Summary report: N

    DONORSCREEN-HLA CLASS I AND CLASS II ASSAY

    MDR report key: 4131198 · Received August 15, 2014

    Report

    Report Number
    2183608-2014-00004
    Date Received
    August 15, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 24, 2014
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    PMA / PMN Number
    BK070045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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)) REGARDING A RUN THAT PRODUCED LOW ASSAY CUTOFF COMPARED TO THEIR HISTORICAL CUTOFFS, WITH DONORSCREEN-HLA ASSAY LOT 3000773A. CUSTOMER ATTRIBUTES LOW ASSAY CUTOFF TO AN ABERRANT NEGATIVE SERUM CONTROL (NC) REPLICATE, AND BELIEVES THAT THE LOW ASSAY CUTOFF CONTRIBUTED TO HIGH NUMBER OF POSITIVE SAMPLES. THE RUN HAD A REACTIVE RATE OF 44%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491709 DONORSCREEN-HLA CLASS I AND CLASS II ASSAY DONORSCREEN-HLA CLASS I AND CLASS II MZI IMMUCOR GTI DIAGNOSTICS, INC. NA 3000773A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA