BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 1408519 · Received July 2, 2009

    Report

    Report Number
    1034569-2009-00216
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Date of Event
    June 8, 2009
    Report Date
    June 24, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RECEIVED THE EXPECTED RESULTS USING ANOTHER LOT OF CRRIC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION. A DONOR SAMPLE RESULTED K-, WHEN TESTED USING CAPTURE-R READY INDICATOR CELLS (CRRIC) LOT 221369.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR CELLS ANTI-GLOBULIN COATED RED BLOOD CELLS KSZ IMMUCOR 221369

    Patients

    Seq Age Sex Outcome Treatment
    1