BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 3243391 · Received July 23, 2013

    Report

    Report Number
    1034569-2013-00126
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    April 19, 2013
    Report Date
    July 23, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES FOR THE UNEXPECTED REACTIVITY WERE REVIEWED AND RESULTS VISUALLY APPEARED AS REPORTED BY THE INSTRUMENT. THE UNEXPECTED NEGATIVE REACTIVITY APPEARS TO BE RELATED TO THE DEVELOPING ANTI-JKA IN THE PATIENT'S SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED ON GALILEO NEO 90203 WITH A SAMPLE THAT APPEARS TO BE DEVELOPING AN ANTI-JKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344510 GALILEO NEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR