BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2211588 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02737
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 31, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD APPLICATIONS SPECIALIST WAS ONSITE AND RAN PRELIMINARY DIAGNOSTIC TESTING AND FOUND THE INC 52 TESTING FAILED. DUE TO THIS PRELIMINARY HARDWARE TROUBLESHOOTING FAILURE, FIELD SERVICE WAS DISPATCHED TO FURTHER INVESTIGATE THE SYSTEM. THE FSE INSPECTED THE INSTRUMENT AND FIXED THE HARDWARE ISSUE. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED IN THIS EVENT A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THIS IS 11 OF 14 SEPARATE MDR REPORTS RELATED TO 14 PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REFERENCE MDR NUMBERS 2122870-2011-02726, 2122870-2011-02727, 2122870-2011-02728, 2122870-2011-02729, 2122870-2011-02730, 2122870-2011-02732, 2122870-2011-02733, 2122870-2011-02734, 2122870-2011-02735, 2122870-2011-02736, 2122870-2011-02738, 2122870-2011-02739, 2122870-2011-02740 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 THROUGH (B)(6) 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 IN THE RISK STRATIFICATION RANGE FOR FOURTEEN PATIENTS. THE RESULTS WERE GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-RAN THE SAMPLE AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT 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 DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI