BEUDAMED
    FDA Adverse Event Other Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 956017 · Received August 23, 2006

    Report

    Report Number
    2250051-2006-50373
    Event Type
    Other
    Date Received
    August 23, 2006
    Date of Event
    August 14, 2006
    Report Date
    August 23, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED PT SAMPLE CONTAINING ANTI-E DID NOT REACT WITH THE E POSITIVE CELLS IN THE 0.8% RESOLVE PANEL A, LOT 8RA198. NO DEATH, OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGEND BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA 8RA198

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other