BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2991417 · Received March 6, 2013

    Report

    Report Number
    1034569-2013-00046
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE INITIAL ABO FORWARD TESTING RESULTS, REACTIONS APPEARED AS REPORTED BY THE INSTRUMENT. THERE WERE NO ERRORS NOTED. THE CUSTOMER TESTED NEW DONOR SEGMENTS ON THE GALILEO AND THE EXPECTED A POSITIVE RESULTS WERE OBTAINED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE UNEXPECTED REACTIVITY APPEARS TO BE USER ERROR OR SAMPLE-RELATED. THE PRODUCT IS PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN ABO MISTYPE OCCURRED WITH KNOWN TYPE A POSITIVE DONOR SAMPLES ON GALILEO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94960 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1