BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1022985 · Received April 3, 2008

    Report

    Report Number
    1034569-2008-00085
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 21, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL REVEALED THAT THE WASHER MANIFOLD CONTAINED BUILDUP. THE WASHER MANIFOLD WAS CLEANED. DURING THE VISIT, THE ENGINEER, CHECKED AND ADJUSTED WASHER FLOWRATES, CHECKED RESIDUAL VOLUME, VERIFIED WASHER TEACH POSITIONS, CHECKED MANIFOLD TIPS AND ALIGNMENT; ALL WERE ACCEPTABLE. DAILY MAINTENANCE, INCLUDING READER PERFORMANCE, WAS PERFORMED WITH ACCEPTABLE RESULTS. SAMPLES RAN WITH EXPECTED RESULTS. THE SYSTEM OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, UNEXPECTED NEGATIVE ANTIBODY SCREEN REACTIONS ON GALILEO USING POOLED SCREENING CELLS; AN ANTI-K WAS NOT DETECTED IN AN AUTOLOGOUS 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