BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 2171179 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02098
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 RAN A SYSTEM CHECK WHICH FAILED THE WASHED AND SUBSTRATE MEANS. THE RESULTS WERE OUT OF SPECIFICATIONS HIGH. THE FSE PERFORMED AND COMPLETED THE SUBSTRATE DECONTAMINATION PROCEDURE. THE FSE THEN REPEATED THE SYSTEM CHECK PROCEDURE WHICH PASSED. THE FSE RECALIBRATED ALL TESTS AND QUALITY CONTROL (QC) RESULTED WITHIN RANGE. THE FSE VERIFIED ALL THE REPAIRS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 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 I) RESULT GENERATED ON THE SYNCHRON LXI 725 CLINICAL SYSTEM TWO PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULT WAS REPORTED OUTSIDE THE LAB. THE PT SAMPLE WAS RETESTED ON A DIFFERENT INSTRUMENT AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    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