BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 CLINICAL SYSTEM

    MDR report key: 2180936 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02785
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    January 31, 2010
    Report Date
    January 31, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K965240
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE FSE REPLACED THE GLUCOSE MODULE. ALTHOUGH PARTS WERE REPLACED, A SPECIFIC ROOT CAUSE OF THIS EVENT WAS NOT 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 OF FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW GLUCOSE RETEST RESULT WAS GENERATED BY THE SYNCHRON LX20 CLINICAL SYSTEM. THE RETEST RESULT IS APPROX 20MG/DL LOWER THAN THE INITIAL RESULT. THE SAMPLE WAS RETESTED ON A DIFFERENT SYSTEM AND YIELDED A RESULT CLOSER TO THE ORIGINAL RESULT. THE RESULT FROM THE RETEST ON THE DIFFERENT SYSTEM WAS REPORTED OUT OF THE LAB. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT'S TREATMENT OR CARE. THERE IS NO REPORT OF ANY ADVERSE EVENT OR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE AND A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LX GLUCOSE 2X2L