BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESOLVE PANEL C

    MDR report key: 741082 · Received July 20, 2006

    Report

    Report Number
    2250051-2006-50312
    Event Type
    Other
    Date Received
    July 20, 2006
    Date of Event
    July 7, 2006
    Report Date
    July 20, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT'S SAMPLES CONTAINING ANTI-E WAS NOT DETECTED WITH RESOLVE PANEL C, LOT RC316. TREATED AND UNTREATED, WHEN TESTED IN GEL. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLVE PANEL C REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA RC316

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other