BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 1113703 · Received May 30, 2008

    Report

    Report Number
    2250051-2008-70279
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 3, 2008
    Report Date
    May 30, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PT CONFIRMED TO HAVE AN ANTI-E HAD FAILED TO REACT WITH THE 0.8% RESOLVE PANEL A WHEN TESTED IN THE MTS GEL SYSTEM. CUSTOMER STATED THERE WERE NO DISCREPANCIES WITH THE DAILY QC. NO ERRONEOUS RESULTS WERE REPORTED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA VS185

    Patients

    Seq Age Sex Outcome Treatment
    1 *