BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 3821801 · Received May 20, 2014

    Report

    Report Number
    1034569-2014-00078
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 26, 2014
    Report Date
    May 20, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE REVIEW OF THE WELL IMAGES WAS CONSISTENT WITH THE GALILEO NEO INTERPRETATION. NO PATIENT SAMPLE OR CUSTOMER PRODUCT WAS RETURNED TO IMMUCOR FOR IMMUCOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTEDLY ABO MISTYPE RESULT WHEN TESTING WITH A GALILEO NEO INSTRUMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299006 GALILEO NEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR