BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1253491 · Received December 9, 2008

    Report

    Report Number
    1034569-2008-00578
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    November 10, 2008
    Report Date
    December 1, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE ADDTIONAL INFORMATION ABOUT THE SAMPLE RESULTS, OR RETURN SAMPLES FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY HAVE SEEN AN 85% CONCORDANCE WITH THE GALILEO FOR ANTIBODY TESTING COMPARED TO RESULTS OBTAINED USING TUBE METHOD WITH PEG AFTER A RECENT UPGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. 10012

    Patients

    Seq Age Sex Outcome Treatment
    1