BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLEDEX TUBE TEST OF HEMOGLOBIN S

    MDR report key: 473989 · Received July 23, 2003

    Report

    Report Number
    2250051-2003-00919
    Event Type
    Malfunction
    Date Received
    July 23, 2003
    Date of Event
    July 15, 2003
    Report Date
    July 15, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    GHM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT WITH A HEMOGLOBIN S OF 22%, AS DETERMINED BY HEMOGLOBIN ELECTROPHORESIS, TESTED NEGATIVE WITH THIS PRODUCT. NO REPORTED DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SICKLEDEX TUBE TEST OF HEMOGLOBIN S NA GHM ORTHO-CLINICAL DIAGNOSTICS, INC. NI 1195

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO