BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI725 CLINICAL SYSTEM

    MDR report key: 2211583 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02714
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 25, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE ON 06/26/2008 INVESTIGATING THE EVENT. THE FSE REPORTED THAT THE LUMINOMETER WAS NOT FUNCTIONING CORRECTLY. THE FSE REPLACED THE PART AND VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. HARDWARE ISSUE WAS ADDRESSED BY THE FSE. HOWEVER, THE CUSTOMER IGNORED MULTIPLE EVENT LOG EVENTS DURING THE TIME THE PATIENT SAMPLES WERE RUNNING. CUSTOMER ERROR IS THE ROOT CAUSE FOR THIS EVENT. THIS IS THREE OF THREE SEPARATE MDR REPORTS RELATED TO THREE PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: MDR 2122870-2011-02712, MDR 2122870-2011-02713, MDR 2122870-2011-02714 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THROUGH 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 HUMANTYTHROID STIMULATING HORMONE (HTSH) RESULTS GENERATED ON THE SYNCHRON LXI 725 CLINICAL SYSTEM FOR ONE PATIENT. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT SAMPLE WAS RETESTED ON A DIFFERENT 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 SYNCHRON LXI725 CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization ACCESS HTSH