BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1061886 · Received June 20, 2008

    Report

    Report Number
    1034569-2008-00190
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 16, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ROIS WERE REVIEWED USING REMOTE ACCESS TO THE INSTRUMENT; IT APPEARED THAT THEY NEED TO BE ADJUSTED. THE ROIS AND AUTOMATIC CAMERA WERE ADJUSTED AND RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2 OCCURRENCES OF DONOR SAMPLES WHERE THE AB ID WAS PERFORMED AND THE SAMPLE WAS SCORED AS NEGATIVE, BUT THE PLATE WAS VISUALLY REVIEWED AND DETERMINED TO BE DIFFERENT THAN THE GALILEO READING.

    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