BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1220023 · Received November 6, 2008

    Report

    Report Number
    1034569-2008-00540
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 14, 2008
    Report Date
    November 4, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS MADE. INVESTIGATION REVEALED THE WASHER MODULE NEEDED TO BE REPLACED. THE COMPLANT WAS RESOLVED BY REPLACING WASHER. AFTER THE SERVICE, THE SAMPLE WAS REPEATED ON THE GALILEO AND RESULTED AS POSITIVE. THE INSTRUMENT WAS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE HAD BEEN TESTED ON THE GALILEO FOR THE DAT ASSAY AND HAD RESULTED AS NEGATIVE, BUT MANUAL TUBE TESTING HAD RESULTED AS 1+ AND MICRO POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. 10049

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR