BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 2351722 · Received November 18, 2011

    Report

    Report Number
    2122870-2011-05390
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    July 4, 2008
    Report Date
    July 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 EVENT. THE FSE PERFORMED A PREVENTATIVE MAINTENANCE ON THE INSTRUMENT. THE FSE REPLACED THE LUMINOMETER DUE TO A SPILL THAT HAD SHORTED OUT THE ATTACHED CABLE. THE FSE ALSO REPLACED THE TRANSDUCER BECAUSE IT WAS OPERATING AT HALF OF THE STATED SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. MDR # 2122870-2008-227 DOCUMENTS THE RESULTS FOR PT 1. THIS IS 5 OF 6 SEPARATE MR REPORTS RELATED TO 6 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REFERENCE MDR NUMBERS MDR 2122870-2008-227, 05387, 05388, 05389, 05391 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 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) RESULTS GENERATED ON THE SYNCHRON LXI 725 CLINICAL SYSTEM FOUR SIX PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. 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