BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN

    MDR report key: 1222664 · Received November 10, 2008

    Report

    Report Number
    1034569-2008-00552
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 7, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A SAMPLE CONTAINING A KNOWN ANTI-F WAS INTERPRETED AS NEGATIVE ON GALILEO USING CAPTURE-R READY SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K150

    Patients

    Seq Age Sex Outcome Treatment
    1