BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLEDEX

    MDR report key: 650084 · Received November 29, 2005

    Report

    Report Number
    2250051-2005-50561
    Event Type
    Malfunction
    Date Received
    November 29, 2005
    Date of Event
    October 31, 2005
    Report Date
    November 28, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JCM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A NEGATIVE REACTION WAS OBSERVED WITH A HEMOGLOBIN S PATIENT. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SICKLEDEX NA JCM ORTHO-CLINICAL DIAGNOSTICS, INC. NA 5172

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other