BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1192585 · Received October 10, 2008

    Report

    Report Number
    1034569-2008-00488
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 9, 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

    THE DIAGNOSTIC ARCHIVE WAS NOT ABLE TO BE RETRIEVED FROM THE INSTRUMENT, SINCE IT WAS DELETED AFTER 30 DAYS. A SERVICE CALL WAS MADE. THE RAM TEST WAS PERFORMED 3 TIMES ON EACH OF THE CUSTOMER'S GALILEOS, AND PASSED EACH TIME. THE SYSTEM OPERATED WITHIN SPECIFICATIONS WITH NO PROBLEMS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SAMPLE BARCODE WAS MISREAD ON GALILEO. DURING VALIDATION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANAYLZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1