BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1242343 · Received November 26, 2008

    Report

    Report Number
    1034569-2008-00570
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 25, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED A SOFTWARE COMPATIBILITY ISSUE. THE INTENDED BEHAVIOR OF THE INSTRUMENT IS TO INVALIDATE THE PLATE AND GENERATE NO RESULTS. IN THIS CASE, A REPORT WAS GENERATED AND THE SAMPLE WELLS WERE GIVEN VALID RESULTS. THIS COULD RESULT IN ERRONEOUS RESULTS BEING RELEASED FOR A PATIENT SAMPLE. THE CUSTOMER WAS INSTRUCTED TO REVIEW ALL CONTROL REACTIONS BEFORE ACCEPTING THE PLATE RESULTS UNTIL THE SOFTWARE BUG COULD BE FIXED. THE PREVIOUS VERSION OF THE AFFECTED FILES WERE INSTALLED ON THE CUSTOMER'S INSTRUMENT RETURNING THE INSTRUMENT BACK TO EXPECTED FUNCTION. THIS WAS THE ONLY INSTRUMENT IN THE FIELD THAT HAD THE SOFTWARE UPGRADE 20080-04 (REV 2) AND THE SOFTWARE BUG WAS DETECTED DURING INSTALLATION OF THE SOFTWARE UPGRADE. THE SOFTWARE BUG HAS BEEN CORRECTED BY THE SOFTWARE MANUFACTURER; ALL FUTURE UPGRADES WILL USE THE 2008-04 (REV 3) CONFIGURATION SET.

    Description of Event or Problem · 1

    WHILE PERFORMING THE OQ FOR THE LATEST SOFTWARE UPGRADE 2008-04 (REV 2), THE APPLICATION SPECIALIST REPORTED THAT, DESPITE INVALID POSITIVE CONTROL WELLS, THE SAMPLE WELLS WERE GIVEN VALID RESULTS. THE EXPECTED BEHAVIOR OF THE INSTRUMENT IN THE EVENT OF A CONTROL FAILURE IS THAT THE ENTIRE PLATE WOULD BE INVALIDATED AND NO RESULTS WOULD BE GENERATED. THIS WAS DETECTED DURING VALIDTION OF THE INSTRUMENT, ACTUAL PATIENT TESTING WAS NOT IMPACTED.

    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