BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 5695060 · Received June 2, 2016

    Report

    Report Number
    1034569-2016-00119
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 4, 2016
    Report Date
    June 2, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE RESULT FILES SHOWED THAT REACTIONS APPEARED AS REPORTED BY THE INSTRUMENT. A SERVICE CALL WAS MADE AND THE INSTRUMENT WAS FOUND TO BE PERFORMING WITHIN SPECIFICATIONS. CUSTOMER DOES NOT KNOW IF THE SAMPLE CONTAINED PASSIVELY ADMINISTERED ANTI-D.

    Description of Event or Problem · 1

    ON 04MAY2016 IMMUCOR BECAME AWARE OF AN UNEXPECTED NEGATIVE RESULT ON THE GALILEO INSTRUMENT WHEN PERFORMING A 2 CELL SCREEN ON A PATIENT SAMPLE. THE SAMPLE CONTAINED AN ANTI-D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350906 GALILEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1