BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 3932977 · Received July 14, 2014

    Report

    Report Number
    1034569-2014-00116
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 18, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES ON (B)(4) 2014. AN IMMUCOR FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE ON (B)(4) 2014, WHEN IT WAS FOUND THAT THE ACTIVE WASH WAS NOT FUNCTIONING CORRECTLY. THE RESOLUTION WAS TO REPLACE THE ACTIVE WASH PUMP. THE INSTRUMENT THEN PERFORMED CORRECTLY WITH THE EXPECTED RESULTS OF SOME TEST BLOOD SAMPLES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN USING CAPTURE-R READY-SCREEN (POOLED CELLS) WHEN TESTING A BLOOD SAMPLE ON A GALILEO NEO ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410677 GALILEO NEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1