BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1068284 · Received July 7, 2008

    Report

    Report Number
    1034569-2008-00239
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 2, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FWD_ABORH TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO WITH THE CUSTOMER'S DONOR SEGMENT AND IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES, USING RETURNED AND RETENTION ANTI-A, LOT 101682, AND ANTI-B SERIES 3, LOT 203236. ALL IN-HOUSE DONOR SAMPLES WERE INTERPRETED AS EXPECTED. THE RETURNED SAMPLE WAS INTERPRETED AS A POSITIVE, WITH RETURNED AND RETENTION PRODUCTS.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT AN ABO MISTYPE. A KNOWN A POSITIVE DONOR SAMPLE WAS TESTED ON THE GALILEO (FWD_ABORH ASSAY) AND IT REPORTED AS AN AB POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1