BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A FOR GEL

    MDR report key: 1180583 · Received July 18, 2008

    Report

    Report Number
    2250051-2008-70337
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 19, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ORTHO CLINICAL DIAGNOSTICS, INC TO REPORT A SAMPLE WITH ANTI-E IS FAILING TO REACT WITH 0.8% RESOLVE PANEL A LOT # VRA116. NO DISCREPANCIES WERE REPORTED WITH QC TESTING. NO DEATH OR SERIOUS INJURY HAS BEEN ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA VRA116

    Patients

    Seq Age Sex Outcome Treatment
    1 *