BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1252763 · Received December 9, 2008

    Report

    Report Number
    1034569-2008-00585
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    November 14, 2008
    Report Date
    December 3, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FWD_ABORH TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES USING RETENTION ANTI-B SERIES 3, LOT 203238, ON AN IN-HOUSE GALILEO. NO ABO DISCREPANCIES WERE OBSERVED. FWD_ABORH TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED SAMPLES RETENTION ANTI-B SERIES 3, LOT 203238, ON AN IN-HOUSE GALILEO. BOTH SAMPLES WERE INTERPRETED AS A POSITIVE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ABO DISCREPANCY ON THE GALILEO WHEN PERFORM FWD ABO ASSAY TESTING WITH A DONOR SAMPLE. UNEXPECTED POSITIVE REACTIONS WERE OBSERVED WITH ANTI-B SERIES 3. THE SAMPLE WAS INTERPRETED AS AB POSITIVE ON GALILEO. TUBE TESTING RESULTS WITH A NEW SAMPLE FROM THE DONOR UNIT WERE A POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK INSTRUMENT KSZ IMMUCOR, INC. 203238

    Patients

    Seq Age Sex Outcome Treatment
    1