BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 2211592 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02720
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2008 INVESTIGATING THE EVENT. THE FSE REPLACED THE PERI-PUMP TUBING AND ASPIRATE PROBES. THE FSE ALSO CLEANED THE PERI-PUMP AND FOUND THAT THE PRECISION VALVE WAS LOOSE ON THE SHAFT AND THE PIN NEARLY FALLING OUT. THE FSE REPLACED THE ROTOR, CLEANED THE WASH VALVE, RAN A SYSTEM CHECK, LUMWASH SON/INC. TESTING, AND 20 POINT PRECISION TESTING WHICH ALL MET SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. THIS IS 2 OF 5 SEPARATE MDR REPORTS RELATED TO 5 PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: MDR 2122870-2011-02719, MDR 2122870-2011-02721, MDR 2122870-2011-02722, MDR 2122870-2011-02723 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 GENERATED ON THE SYNCHRON LXI 725 CLINICAL SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT 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 LXI 725 CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR ACCESS ACCUTNI