BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN (POOLED CELLS)

    MDR report key: 1613823 · Received February 24, 2010

    Report

    Report Number
    1034569-2010-00049
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 23, 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 FILES: PLATE CONTAINED SAMPLE IN WELL C10: C10- NEG REACTION/ 13 REACTION STRENGTH- VISUALLY THERE IS A CELL BUTTON PRESENT WITH A PINK BACKGROUND. REVIEW OF LABELING: AS 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULTS WHEN TESTING A DONOR SAMPLE WITH CAPTURE-R READY SCREEN (POOLED CELLS) (CRRS POOLED) ON THE GALILEO. THE SAMPLE HAS A KNOWN ANTI-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN (POOLED CELLS) REAGENT RED BLOOD CELLS KSZ IMMUCOR N230

    Patients

    Seq Age Sex Outcome Treatment
    1