BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1171703 · Received September 24, 2008

    Report

    Report Number
    1034569-2008-00473
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 24, 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

    CUSTOMER WAS INFORMED OF THE LIMITATION STATED IN THE OPERATOR'S MANUAL THAT FORWARD ONLY TYPING HAS AN INCREASED RISK OF MISTYPE, DUE TO THE ABSENCE OF THE REVERSE TYPING. CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION TESTING. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY ON GALILEO DURING DONOR CONFIRMATION WITH THE FWDABO ASSAY. THE UNIT WAS LABELED AS A NEGATIVE, BUT WHEN TESTED ON THE GALILEO RESULTED AS A POSITIVE.

    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