BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLEDEX TUBE TEST OF HEMOGLOBIN S

    MDR report key: 490468 · Received October 3, 2003

    Report

    Report Number
    2250051-2003-01134
    Event Type
    Malfunction
    Date Received
    October 3, 2003
    Date of Event
    September 4, 2003
    Report Date
    September 30, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    GHM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT SAMPLE THAT REACTED POSITIVE IN MAY IS NOW REACTING NEGATIVE. 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 3070

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other