BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN

    MDR report key: 585593 · Received June 18, 2004

    Report

    Report Number
    2250051-2004-02636
    Event Type
    Malfunction
    Date Received
    June 18, 2004
    Date of Event
    June 4, 2004
    Report Date
    June 18, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A PT SAMPLE CONTAINING ANTI-E DID NOT REACT WITH 8S613.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS 719601 8S613

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other