BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2192383 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02675
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA TUBE AND CENTRIFUGED IN A POWER PROCESSOR CENTRIFUGE FOR 4 MINUTES. ACCUTNI CALIBRATION PERFORMED ON (B)(6) 2011 PASSED. SYSTEM CHECK PERFORMED ON (B)(6) 2011 ALSO PASSED. LEVELS 1 AND 3 ACCUTNI QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DATE OF EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THE EVENT. THE FSE REPLACED THE PARTICLE PUMP AND THE 2 WASH PUMPS. THE FSE ALSO RAN A SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK, WHICH PASSED. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING AN ERRONEOUS TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT. THE ELEVATED ACCUTNI RESULT WAS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 110410) AND ACCESS ACCUTNI CALIBRATOR (LOT 023153). SUBSEQUENT TESTING ON THE SAME INSTRUMENT PRODUCED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. RESULTS ARE SHOWN. THE ELEVATED ACCUTNI RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER WAS UNSURE IF PATIENT TREATMENT WAS CHANGED DUE TO REPORTED ERRONEOUS RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1