BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1205444 · Received October 22, 2008

    Report

    Report Number
    1034569-2008-00516
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 21, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DOES NOT HAVE SAMPLE TO RETURN FOR INVESTIGATION TESTING. FWD_ABORH TESTING PERFORMED WITH IN-HOUSE DONOR SAMPLES OF VARIOUS ABO/RH TYPES USING RETENTION ANTI-A, LOT 101680, AND ANTI-B SERIES 3, LOT 203234, ON IN-HOUSE GALILEO. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. THE GALILEO OPERATOR MANUAL STATES THAT THE FWD ABO ASSAY HAS A HIGHER RISK OF MISTYPE DUE TO THE ABSENCE OF THE REVERSE TYPE RESULTS. HAZARDOUS MISTYPES MAY OCCUR, SUCH AS AN A SAMPLE BEING INTERPRETED AS GROUP AB, OR AN RH D NEGATIVE SAMPLE BEING INTERPRETED AS RH D POSITIVE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO DISCREPANCY WITH THE FWD ABO ASSAY ON GALILEO. A PATIENT, A HISTORICALLY A POSITIVE, TESTED AS AN A POSITIVE ON THE GALILEO, BUT REPEAT CONFIRMATION TESTING WITH THE FWDABO ASSAY RESULTED AS AB POSITIVE ON THE GALILEO.

    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 34 YR