BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID TEST WELLS

    MDR report key: 1022987 · Received April 3, 2008

    Report

    Report Number
    1034569-2008-00087
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 21, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN PRODUCTS STATES THAT PASSIVELY ACQUIRED ANTI-D MAY FAIL TO REACT BY CAPTURE-R READY SCREEN, EVEN THOUGH ANITBODIES ARE DETECTED BY AN ALTERNATIVE TECHNIQUE. THE NATURE OF THE SAMPLE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SAMPLE HAD CONFLICTING REACTIVITY WITH CAPTURE-R READY-ID ON DIFFERENT ECHOS. A PATIENT SAMPLE HAD A POSITIVE ANTIBODY ID ON ECHO, AND HAD A NEGATIVE ANTIBODY ID ON ANOTHER ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-ID TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID098

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR