BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 2394270 · Received November 15, 2011

    Report

    Report Number
    2122870-2011-05292
    Event Type
    Malfunction
    Date Received
    November 15, 2011
    Date of Event
    August 24, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008, TO INVESTIGATE THE INSTRUMENT. THE FSE CLEANED THE WASH CAROUSEL, PERFORMED A PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT AND VERIFIED THE SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. MDR# 2122871-2011-302 DOCUMENTS THE RESULTS FOR PT 1. THIS IS 4 OF 5 SEPARATE MDR REPORTS RELATED TO 5 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: MDR 2122870-2011-05290, 05291, 05292, 05293 FOR ALL RELATIVE EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADD¿L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULTS FOR FIVE PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE PT SAMPLE WAS RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. 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 SYNCHRON LXI 725 CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI