BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1061899 · Received June 20, 2008

    Report

    Report Number
    1034569-2008-00197
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 18, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL BARCODE WAS NOT AVAILABLE TO SEND. IF THIS BARCODE IS NOT AVAILABLE, A PROPER INVESTIGATION IS NOT POSSIBLE. CUSTOMER WAS NOT ABLE TO REPRODUCE THE MISREAD WITH THE BARCODE IN QUESTION. A SERVICE CALL WAS MADE. THE SAMPLE LOADING BAY WAS REPLACED; THE INSTRUMENT OPERATED AS EXPECTED. CUSTOMER HAD NO MORE PROBLEMS WITH BARCODES NOT READING CORRECTLY ON THE GALILEO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SAMPLE BARCODE SCANNED INCORRECTLY ON THE GALILEO WHILE RUNNING ABO ASSAYS. ACTUAL BARCODE IS ES85045963, BUT IT WAS READ ON GALILEO AS ES85041963.

    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