BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 1105783 · Received August 13, 2008

    Report

    Report Number
    1034569-2008-00317
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 11, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING ON THE INSTRUMENT PERFORMED AS EXPECTED WHEN NEW LOT OF CRRIC WAS USED TO REPEAT ANTIBODY ID TESTING. THE PRODUCT EXPIRED PRIOR TO RECEIVING THE COMPLAINT; THEREFORE, NO ADDITIONAL SEROLOGICAL TESTING WAS PERFORMED. THE LOT RELEASE RECORDS FOR CRRIC, LOT 221203, WERE REVIEWED. THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN RUNNING ANTIBODY ID TESTING ON A PATIENT SAMPLE CONTAINING ANTI-E USING CAPTURE-R READY INDICATOR CELLS (CRRIC) ON THE ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR CELLS INDICATOR CELLS KSZ IMMUCOR, INC. 22103

    Patients

    Seq Age Sex Outcome Treatment
    1