BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL B

    MDR report key: 1153304 · Received July 2, 2008

    Report

    Report Number
    2250051-2008-70308
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 4, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ORTHO CLINICAL DIAGNOSTICS, INC TO REPORT A FALSE NEGATIVE REACTION WITH A PT CONFIRMED TO HAVE AN ANTI-C. 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 B REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA VRB115

    Patients

    Seq Age Sex Outcome Treatment
    1 *