BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1964404 · Received January 19, 2011

    Report

    Report Number
    2050012-2011-00185
    Date Received
    January 19, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED QC FLIERS WERE NOTED AT THE TIME OF THE EVENT. THE CUSTOMER PERFORMED TWICE WEEKLY MAINTENANCE AND REPLACED THE NA ELECTRODE. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTIVE MAINTENANCE. THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH ION-SELECTIVE ELECTRODE (ISE) RESULTS GENERATED BY THE SYNCHRON LX 20 PRO CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND LOWER RESULTS WERE OBTAINED. THE CUSTOMER PROVIDED ONE EXAMPLE FROM ONE PATIENT WHICH IS SHOWN. PATIENTS TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1