BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN (POOLED)

    MDR report key: 1715763 · Received June 10, 2010

    Report

    Report Number
    1034569-2010-00128
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 10, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES WERE DOWNLOADED FROM THE CUSTOMER'S INSTRUMENT AND RESULTS WERE VERIFIED. THE LIMITATIONS SECTION OF THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN STATES: "ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED BLOOD CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED BLOOD CELLS OF UNPOOLED SINGLE DONORS. POOLED REAGENT RED BLOOD CELLS SHOULD NOT BE USED WHEN THE ANTIGLOBIN ANTIBODY SCREEN IS PERFORMED IN PLACE OF THE ANTIGLOBIN CROSSMATCH."

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A SAMPLE WITH CAPTURE-R READY SCREEN POOLED (CRRS POOLED) ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN (POOLED) REAGENT RED BLOOD CELLS KSZ IMMUCOR N242

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR