BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1234625 · Received November 20, 2008

    Report

    Report Number
    1034569-2008-00564
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 19, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ABORH TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES USING RETENTION ANTI-A, LOT 101676, ANTI-B SERIES 3, LOT 203228, AND ANTI-D SERIES 4, LOT 504696, ON AN IN-HOUSE GALILEO. THESE LOTS WERE USED BY THE CUSTOMER AT THE TIME OF THE EVENT. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. FWD_ABORH TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED DONOR SAMPLES USING RETENTION ANTI-A, LOT 101676, ANTI-B SERIES 3, LOT 203228, AND ANTI-D SERIES 4, LOT 504696, ON AN IN-HOUSE GALILEO. RESULTS OBTAINED MATCHED THE CUSTOMER'S MANUAL TYPING RESULTS.

    Description of Event or Problem · 1

    CUSTOMER INDICATED ABO DISCREPANCIES OCCURRED ON DONOR SAMPLES TESTED ON GALILEO. THE CUSTOMER STATED NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE ABO DISCREPANCIES.

    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