BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLEDEX TUBE TEST OF HEMOGLOBIN S

    MDR report key: 473997 · Received July 23, 2003

    Report

    Report Number
    2250051-2003-00920
    Event Type
    Malfunction
    Date Received
    July 23, 2003
    Date of Event
    December 16, 2002
    Report Date
    July 15, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    GHM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TWO SPECIMENS FROM INDIVIDUALS KNOWN TO BE POSITIVE FOR 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 OF HEMOGLOBIN S NA GHM ORTHO-CLINICAL DIAGNOSTICS, INC. NI 2015

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO