BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2152100 · Received July 7, 2011

    Report

    Report Number
    2122870-2011-02160
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLW
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND PRE-ANALYTICAL SAMPLE HANDLING INFORMATION WAS NOT PROVIDED. QC AND SYSTEM CHECK DATA HAVE NOT BEEN SUPPLIED TO DATE. SERVICE INFORMATION HAS NOT BEEN SUPPLIED TO DATE. A PATIENT SAMPLE INTERFERANT IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IN 2010, THE CUSTOMER OBTAINED AN ERRONEOUSLY ELEVATED THYROID-STIMULATING HORMONE (TSH) RESULT, ABOVE THE NORMAL REFERENCE RANGE, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE PATIENT WAS DIAGNOSED AS HAVING A HYPOTHYROID CONDITION AND WAS TREATED WITH EUTIROX. WHEN IT WAS DETERMINED THE PATIENT "DID NOT RESPOND" TO THE TREATMENT, REPEAT TESTING WAS PERFORMED ON AN ALTERNATE METHODOLOGY WHICH PRODUCED "NORMAL" TSH RESULTS. A PATIENT SAMPLE WAS SENT INTO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR INVESTIGATIONAL TESTING. CPLS HETEROPHILE TESTING DEMONSTRATED THE PRESENCE OF INTERFERING SUBSTANCE SINCE AT LEAST ONE OF THE HETEROPHILE BLOCKERS USED IN THE TEST SIGNIFICANTLY LOWERED THE SIGNAL. ADDITIONAL INFORMATION REGARDING CHANGES TO PATIENT TREATMENT HAS NOT BEEN SUPPLIED TO DATE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention