BEUDAMED
    FDA Adverse Event Other Summary report: N

    0.8% RESOLVE A

    MDR report key: 951011 · Received August 11, 2006

    Report

    Report Number
    2250051-2006-50349
    Event Type
    Other
    Date Received
    August 11, 2006
    Date of Event
    June 27, 2006
    Report Date
    August 10, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER PERFORMING PARALLEL TESTING OF 0.8% RESOLVE A, LOT# 8RA197. CUSTOMER STATES THAT PT SAMPLES CONTAINING ANTI-E, -FYE, -S AND PASSIVE ANTI-D WERE MISSED. NO DEATH OR SERIOUS INJURY IS ASSOCATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE A REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA 8RA197

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other