BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 563974 · Received May 24, 2004

    Report

    Report Number
    2250051-2004-02592
    Event Type
    Malfunction
    Date Received
    May 24, 2004
    Date of Event
    May 3, 2004
    Report Date
    May 21, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MWN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A DIALYSIS PT WITH A KNOWN ANTI-KELL RECEIVED 2 UNITS OF KELL-NEGATIVE PACKED CELLS (COMPATIBLE). PT SUFFERED A HEMOLYTIC TRANSFUSION REACTION, POST-TRANSFUSION WORKUP IDENTIFIED ANTI-M AND ANTI-JKS. THE PT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS MWN ORTHO-CLINICAL DIAGNOSTICS, INC. 719501 8RA168

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other