BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGISCREEN

    MDR report key: 809931 · Received October 31, 2005

    Report

    Report Number
    2250051-2005-50491
    Event Type
    Other
    Date Received
    October 31, 2005
    Date of Event
    September 30, 2005
    Report Date
    October 28, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PATIENT'S SAMPLE CONTAINING ANTI-E DID NOT REACT WITH 0.8% SURGISCREEN LOT 8SS359. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISCREEN REAGENT READ BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA 8SS359

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other