BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2192244 · Received August 4, 2011

    Report

    Report Number
    2122870-2011-02742
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS IN A LITHIUM HEPARIN PLASMA TUBE, AND WAS CENTRIFUGED IN A POWER PROCESSOR CENTRIFUGE FOR FOUR (4) MINUTES. PER CUSTOMER PROVIDED DATA, THE CUSTOMER HAD A PASSING ACCUTNI CALIBRATION ON (B)(6) 2011. SERVICE WAS DISPATCHED FOR THIS EVENT AND ON-SITE ON (B)(6) 2011. THE FIELD SERVICE ENGINEER (FSE) CALIBRATED ALL TRANSDUCERS AND PERFORMED ALIGNMENTS. THE FSE CLEANED THE WASH WHEEL AND WASH VALVES. THE FSE REPLACED ASPIRATE PROBES AND TUBING. THE FSE RAN A HIGH SENSITIVITY SYSTEM CHECK, WHICH PASSED THE SPECIFICATIONS. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULT WAS REPORTED TO ER. HEPARIN AND PLAVIX PROTOCOLS WERE STARTED ON THE PATIENT DUE TO THE ELEVATED RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other