BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® 20 PRO CLINICAL SYSTEM

    MDR report key: 1961965 · Received January 15, 2011

    Report

    Report Number
    2050012-2011-00168
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS OUT OF THE ESTABLISHED RANGES AFTER THE EVENT, BUT QC RESULTS CAME WITHIN THE ESTABLISHED RANGES AFTER RE-CALIBRATION. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(6) 2010, AND PERFORMED A PREVENTIVE MAINTENANCE (PM). THE FSE NOTICED CRACKING IN RATIO PUMP MIDDLE CHAMBER. THE FSE REPLACED RATIO PUMP CYLINDERS AND RAN QC AND PRECISION TESTS TO VERIFY THE REPAIR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS SODIUM (NA) AND CHLORIDE (CL) RESULTS SPORADICALLY GENERATED BY SYNCHRON LX 20 PRO CLINICAL SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THE EXAMPLE RESULTS ARE SHOWN. THERE WAS NO EFFECT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® 20 PRO CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. LX 20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1