BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1961991 · Received January 17, 2011

    Report

    Report Number
    2122870-2011-00038
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLW
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING REPRODUCIBLE ELEVATED THYROID-STIMULATING HORMONE (TSH) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED LOWER DISCORDANT RESULTS. THE PATIENT WAS PRESCRIBED L-THYROXINE DUE TO THE ELEVATED TSH RESULTS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JLW BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other