BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELECTOGEN

    MDR report key: 695536 · Received September 8, 2005

    Report

    Report Number
    2250051-2005-50381
    Event Type
    Other
    Date Received
    September 8, 2005
    Date of Event
    August 12, 2005
    Report Date
    September 8, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE CONTAINING ANTI-E DID NOT REACT WITH SELECTOGEN LOT S955.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA S955

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other