BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLEDEX TUBE TEST HEMOGLOBIN S

    MDR report key: 473995 · Received July 23, 2003

    Report

    Report Number
    2250051-2003-00917
    Event Type
    Malfunction
    Date Received
    July 23, 2003
    Date of Event
    October 19, 2001
    Report Date
    July 15, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    GHM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT WITH A HISTORY OF SICKLE CELL TRAIT 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 HEMOGLOBIN S NA GHM ORTHO-CLINICAL DIAGNOSTICS, INC. NI 1045

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO