BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2008349 · Received March 6, 2011

    Report

    Report Number
    2122870-2011-00598
    Event Type
    Malfunction
    Date Received
    March 6, 2011
    Date of Event
    June 16, 2010
    Report Date
    February 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS SERUM WHICH WAS CENTRIFUGED AUTOMATICALLY ON POWER PROCESSOR. QC AND/OR SYSTEM CHECK DATA WAS NOT PROVIDED. CUSTOMER IS NOT REPORTING ANY SYSTEM PERFORMANCE ISSUES. NO SYSTEM EVENT LOG MESSAGES REPORTED WITH THIS EVENT. DUE TO THE BELATED REPORTING OF THIS EVENT, SAMPLE WAS UNAVAILABLE FOR TESTING BY CUSTOMER PRODUCT LINE SUPPORT (CPLS). SERVICE WAS NOT DISPATCHED. HETEROPHILE INTERFERENCE IS THE LIKELY ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUSLY ELEVATED THYROID STIMULATING HORMONE (TSH) RESULT FOR A PATIENT GENERATED BY UNICEL DXI 800 ACCESSS CHEMISTRY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN SINCE IT DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. THE SAMPLE WAS REPEATED WITH SCANTIBODIES HRT ON THE SAME UNIT AND LOWER RESULT WAS OBTAINED. IN ADDITION, THE SAMPLE WAS REPEATED ON ALTERNATE METHODOLOGY AT A REFERENCE LABORATORY AND A RESULT WITHIN NORMAL REFERENCE RANGE WAS OBTAINED. AMENDED REPORT WAS INITIATED AND SUBMITTED TO THE PHYSICIAN. PATIENT RESULTS ARE PROVIDED. THE CUSTOMER WAS NOT MADE AWARE OF ANY PATIENT INJURY OR CHANGE IN TREATMENT ASSOCIATED WITH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1