BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLEDEX TUBE TEST FOR HEMOGLOBIN S

    MDR report key: 695791 · Received April 3, 2006

    Report

    Report Number
    2250051-2006-50140
    Event Type
    Malfunction
    Date Received
    April 3, 2006
    Date of Event
    March 2, 2006
    Report Date
    April 3, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    GHM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE RESULT WAS OBTAINED WHEN THE SAMPLE WAS TESTED WITH SICKLEDEX LOT 5250. CUSTOMER RESULTS WERE SATISFACTORY. CUSTOMER OBTAINED A POSITIVE RESULT FOR THE PATIENT'S SAMPLE VIA ELECTROPHORESIS. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SICKLEDEX TUBE TEST FOR HEMOGLOBIN S * GHM ORTHO-CLINICAL DIAGNOSTICS, INC. NA 5250

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other