BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1102403 · Received August 11, 2008

    Report

    Report Number
    1034569-2008-00316
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 8, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT IS OPERATING AS EXPECTED. THE GALILEO OPERATOR MANUAL STATES THAT REAGENTS SHOULD BE INSPECTED FOR THE PRESCENCE OF FOAM BEFORE PLACEMENT ON THE INSTRUMENT. FOAM IN THE VIAL CAN POSSIBLY BE ASPIRATED BY THE LIQUID LEVEL DETECTION FEATURE OF THE PIPETTING SYSTEM. THIS WILL PRODUCE INCORRECT RESULTS OR AN ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO DISCREPANCY ON THE GALILEO ON A DONOR SAMPLE.

    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