BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1233910 · Received November 19, 2008

    Report

    Report Number
    1034569-2008-00561
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 12, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE D ANTIGEN WAS CONFIRMED ON RETENTION CRRS(3), LOT R027. REACTIVTY OF THE D AND E ANTIGENS CONFIRMED ON RETENTION CRRID, LOT ID105. RETENTION PRODUCTS PERFORMED AS EXPECTED. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE ECHO. A PATIENT SAMPLE RESULTED AS NEGATIVE WITH CELL II OF CAPTURE -R READY SCREEN(CRRS)3 AND ALL CELLS OF CAPTURE-R READY ID (CRRID). NO TRANSFUSION OR ADVERSE REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR