BEUDAMED
    FDA Adverse Event Other Summary report: N

    0.8% SELECTOGEN

    MDR report key: 830358 · Received November 11, 2005

    Report

    Report Number
    2250051-2005-50532
    Event Type
    Other
    Date Received
    November 11, 2005
    Date of Event
    October 26, 2005
    Report Date
    November 11, 2005
    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 A PT SAMPLE CONTAINING ANTI-JKA DID NOT REACT WITH 0.8% SELECTOGEN LOT 8S687.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA 8S687

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other