BEUDAMED
    FDA Adverse Event Other Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 535294 · Received February 9, 2004

    Report

    Report Number
    2250051-2004-02448
    Event Type
    Other
    Date Received
    February 9, 2004
    Date of Event
    January 29, 2004
    Report Date
    February 9, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS INCONCLUSIVE RESULTS WITH JKA POSITIVE PT AND RESOLVE PANEL A-8RA165. SURGISCREEN LOT 8SS250 CELL #3 REACTED 1+. RESOLVE PANEL A CELLS 1, 7 AND 8 REACTED 1+. 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 A REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS 719501 8RA165

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other