BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2072873 · Received April 29, 2011

    Report

    Report Number
    1034569-2011-00051
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 29, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE ECHO IMAGE FILES BY IMMUCOR TECHNICAL SERVICES SHOWED THE PRESENCE OF HORIZONTAL LINES ON THE WELL IMAGES FOR THE DISCREPANT RESULTS. THE CUSTOMER STATED THIS WAS THE ONLY OCCURRENCE OF OBSERVING LINES ON WELL IMAGES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN ABO DISCREPANCY HAD OCCURRED ON THE GALILEO ECHO INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1