BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A FOR GEL

    MDR report key: 1231730 · Received August 18, 2008

    Report

    Report Number
    2250051-2008-70407
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 18, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A PT WITH ANTI-E DID NOT REACT WITH VRC117. THE DAILY QC TESTING WAS ACCEPTABLE. NO ERRONEOUS RESULTS WERE REPORTED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC.

    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, INC. * VRC117

    Patients

    Seq Age Sex Outcome Treatment
    1 *