BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 3

    MDR report key: 2181878 · Received July 28, 2011

    Report

    Report Number
    1034569-2011-00104
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 26, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT RESULTS: ALL CELLS FROM CRRS3 RESULTED AS NEGATIVE FOR ALL SCREENING CELLS. REVIEW OF THE WELL IMAGE FOR SCREENING CELL 2 IMAGE SHOWS A BUTTON WITH NO CELL ADHERENCE. ALL CELL FROM CRRID RESULTED AS NEGATIVE. E POSITIVE CELLS ARE 1, 3, 6, AND 7. VISUALLY ALL CELLS APPEAR NEGATIVE. CUSTOMER STATES THAT A KNOWN ANTI-E SAMPLE IS REACTING AS EXPECTED USING THE SAME REAGENTS. CUSTOMER RECEIVED A NEW LOT OF CRRS3 (LOT R163) AND RE-TESTED SAMPLE AND RECEIVED THE EXPECTED RESULTS. THIS ISSUE APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS3) AND CAPTURE-R READY-ID (CRRID) ON THE ECHO. PATIENT HAS A KNOWN ANTI E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R158

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR