BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 3102541 · Received May 9, 2013

    Report

    Report Number
    1034569-2013-00075
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 9, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CLEANED THE WASH MANIFOLD AND REPEATED TESTING. NEGATIVE RESULTS WERE OBTAINED. TESTING WAS PERFORMED USING A DIFFERENT LOT OF CRRS(3) TEST WELLS AND THE FYA CELL RESULTED AS POSITIVE. NEGATIVE RESULTS WERE OBTAINED WITH THE JKA CELL. NO ADDITIONAL SAMPLE IS AVAILABLE FOR INVESTIGATION. THE IMMUCOR PRODUCT INVESTIGATION LAB CONFIRMED THE PRESENCE OF THE FYA AND JKA ANTIGENS ON RETENTION CAPTURE-R READY-SCREEN (3) TEST WELLS. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. RETENTION PERFORMED AS EXPECTED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY ON ECHO M00889 WITH CAPTURE-R READY-SCREEN (3), LOT R287, FOR A SAMPLE WITH A HISTORY OF HAVING ANTI-JKA AND ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204069 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R287

    Patients

    Seq Age Sex Outcome Treatment
    1 89