BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 2261713 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03269
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    December 16, 2009
    Report Date
    December 18, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYZER PERFORMANCE AND SERVICE WAS NOT AVAILABLE FOR THIS ANALYZER. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 3 EVENTS REPORTED BY THIS CUSTOMER. THE 3 RELATED MDRS THAT HAVE BEEN REPORTED ARE: MDR 2122870-2011-03269, MDR 2122870-2011-03270, MDR 2122870-2011-03271.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) RESULTS WERE OBTAINED WHEN USING A SYNCHRON LXI 725 CLINICAL SYSTEM. THE INITIAL RESULT WAS ERRONEOUSLY HIGH. UPON RETESTING, THE RESULTS WERE IN THE NORMAL REFERENCE RANGE. THE RESULTS OBTAINED IN THE NORMAL REFERENCE RANGE WERE CONSIDERED CORRECT. IT IS UNKNOWN IF ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY OR IF THERE WAS ANY AFFECT TO PATIENT TREATMENT. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 1 OF 3 EVENTS REPORTED BY THIS CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 CLINICAL SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR ACCESS ACCU TNI