BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172505 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02016
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 30, 2008
    Report Date
    May 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE INDICATED THAT THE INSTRUMENT IS OPERATING ACCORDING TO SPECIFICATIONS. ALTHOUGH PRE-ANALYTICAL HANDLING IS A LIKELY CONTRIBUTOR TO THIS EVENT, A CLEAR ROOT CAUSE CANNOT BE DETERMINED FROM THE INFO SUPPLIED. THIS IS ONE OF TWO SEPARATE MDR REPORTS RELATED TO TWO PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBER 2122870-2011-02018 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULT WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-RAN THE SAMPLES AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THE CORRECTED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR ACCESS ACCUTNI