BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1173744 · Received September 25, 2008

    Report

    Report Number
    1034569-2008-00474
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 24, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS MADE; RESIDUAL VOLUME WAS TOO LOW AND WAS OPTIMIZED TO MEET SPECIFICATION. GALILEO WAS WITHIN SPECIFICATIONS FOR OPERATION..

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT UNEXPECTED NEGATIVE REACTIONS ON GALILEO. A PATIENT SAMPLE REPORTED AS NEGATIVE ON A 2 CELL_SCREEN. THE SAMPLE WAS REPEATED IN TUBE AND DEMONSTRATED 1+ REACTIVITY FOR ANTI-FYA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1