BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 PRO SYSTEM

    MDR report key: 2211554 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04225
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K011213
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED ONE EXAMPLE OF LOW NA RESULT, NO EXAMPLES OF HIGH CL RESULTS WERE PROVIDED. NO RERUN, CORRECT RESULTS WERE PROVIDED FOR REVIEW. THE FIELD SERVICE ENGINEER (FSE) CONTACTED THE FACILITY BY PHONE TO TROUBLE SHOOT THE SYSTEM. THE CUSTOMER WAS ADVISED TO CLEAN THE FLOW CELL. THE SYSTEM WAS THEN RECALIBRATED; NO FURTHER OCCURRENCES WERE REPORTED. ALTHOUGH THIS MEASURE MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED; ACCORDINGLY NO CONCLUSION CAN BE DRAWN. 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

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM AND HIGH CHLORIDE RESULTS WERE GENERATED BY THE SYNCHRO LX20 PRO SYSTEM. THE SYSTEM OPERATOR QUESTIONED THE RESULTS; NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SYSTEM WAS RECALIBRATED AND RESUMED NORMAL OPERATION AND THE SAMPLES WERE RETESTED. RETESTED RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE EVENTS OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 PRO SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ISE ELECTROLYTE REFERENCE| ISE ELECTROLYTE BUFFER