BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELECTOGEN

    MDR report key: 892815 · Received September 30, 2004

    Report

    Report Number
    2250051-2004-02789
    Event Type
    Other
    Date Received
    September 30, 2004
    Date of Event
    September 14, 2004
    Report Date
    September 30, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ELDERLY PT WITH MULTIPLE MYELOMA EXPERIENCED A HEMOLYTIC TRANSFUSION REACTION DUE TO ANTI-JKB THAT WENT UNDETECTED WHEN TESTED IN TUBE/ALBUMIN WITH SELECTOGEN LOT S844. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA S844

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other