BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL B

    MDR report key: 559491 · Received April 19, 2004

    Report

    Report Number
    2250051-2004-02570
    Event Type
    Malfunction
    Date Received
    April 19, 2004
    Date of Event
    March 25, 2004
    Report Date
    April 19, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS PT WITH ANTI-JKA AND ANTI-K WAS TESTED WITH 0.8% RESOLVE PANEL B LOT 8RB165 ON MTS PROVUE. THE ANTI-K WAS POSITIVE BUT THE ANTI-KJA WAS NOT REACTIVE. NO DEATH OR SERIOUS INJURY WAS 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 719521 8RB165

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other