BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2160008 · Received July 13, 2011

    Report

    Report Number
    1034569-2011-00090
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 11, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECHO CAMERA FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. THE WELL IMAGES LOOKED SLIGHTLY POSITIVE, BUT WERE RESULTING AS NEGATIVE. ON (B)(4) 2011, AN IMMUCOR INSTRUMENT SERVICE ENGINEER PERFORMED THE GALILEO UNEXPECTED REACTION CHECK LIST. THE CAMERA WAS REPLACED. REPEAT TESTING WAS PERFORMED WITH THE PATIENTS SAMPLE. RESULTS WERE IDENTICAL TO TESTING PERFORMED MANUALLY. THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS AND WEAK REACTIVITY WHEN PERFORMING ANTIBODY SCREENING AND IDENTIFICATION ASSAYS 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 84 YR