BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1131423 · Received August 25, 2008

    Report

    Report Number
    1034569-2008-00328
    Event Type
    Malfunction
    Date Received
    August 25, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 18, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS TOLD THE GALILEO OPERATOR MANUAL STATES THAT THE GALILEO CAN NOT RELIABLY DETECT HEMAGGLUTINATION REACTIONS THAT ARE GRADED AS 1+ OR LESS IN TEST TUBE METHODOLOGY. WEAK D TESTING WAS NOT PERFORMED BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY ON A PATIENT SAMPLE TESTED ON GALILEO. GALILEO RESULTS WERE D NEGATIVE. PROVUE RESULTS WERE 3+ FOR ANTI D ON THE SAME 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