BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN (POOLED)

    MDR report key: 1714161 · Received June 9, 2010

    Report

    Report Number
    1034569-2010-00122
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 10, 2010
    Report Date
    June 8, 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

    REVIEW OF RESULTS: VISUALLY THE IMAGES APPEAR TO BE WEAKLY POSITIVE. CANNOT RULE OUT THE NATURE OF THE SAMPLE AS THE CAUSE OF THE UNEXPECTED REACTION. CONFIRMED THE REACTIVITY OF THE FYA ANTIGEN ON RETENTION CRRS3 LOT N237 USING ANTI-FYA. PER THE CRRS (POOLED) PACKAGE INSERT, "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 ANTIGLOBULIN ANTIBODY SCREEN IS PERFORMED IN PLACE OF THE ANTIGLOBULIN 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. THE SAMPLE WAS RE-TESTED ON THE GALILEO AND RESULTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN (POOLED) REAGENT RED BLOOD CELLS KSZ IMMUCOR N237

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR