BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN

    MDR report key: 980690 · Received September 6, 2007

    Report

    Report Number
    2250051-2007-70511
    Event Type
    Malfunction
    Date Received
    September 6, 2007
    Date of Event
    August 10, 2007
    Report Date
    September 6, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT'S SAMPLE CONTAINING ANTI-E WAS NEGATIVE WHEN TESTED WITH 0.8% SURGISCREEN LOT VSS118. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA VSS118

    Patients

    Seq Age Sex Outcome Treatment
    1 *