BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 2960531 · Received February 14, 2013

    Report

    Report Number
    1034569-2013-00035
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    November 30, 2012
    Report Date
    February 14, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE IMAGE RESULT FILES, REACTIONS APPEARED AS REPORTED BY THE INSTRUMENT. NO ADDITIONAL SAMPLE OR DONOR SEGMENTS WERE AVAILABLE FOR INVESTIGATION. AN IMMUCOR FIELD SERVICE ENGINEER PERFORMED THE UNEXPECTED REACTION CHECKLIST. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY ON THE CROSSMATCH ASSAY ON GALILEO NEO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64351 GALILEO NEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR