BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 PRO CLINICAL SYSTEM

    MDR report key: 2221134 · Received August 23, 2011

    Report

    Report Number
    2050012-2011-04713
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. PRIOR TO THE EVENT, TG QC RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CHECKED THE WASH CONCENTRATE DELIVERY SYSTEM. ONE OF CORRESPONDING VALVES (V12) WAS FOUND TO BE LEAKING. THE FSE REPLACED THE VALVE AND THE MIXER WASH STATIONS ON BOTH THE SAMPLE AND REAGENT SIDES. THE REPAIRS WERE VERIFIED BY RUNNING PRECISION STUDIES YIELDING SUFFICIENT RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING SEVEN (7) ERRONEOUSLY HIGH MAGNESIUM (MG) PATIENT RESULTS GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE RESULTS WERE REPEATED ON AN ALTERNATE INSTRUMENT AND GENERATED LOWER RESULTS. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. NO FALSE RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 PRO CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR