BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1760326 · Received July 16, 2010

    Report

    Report Number
    2050012-2010-00445
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER NOTICED THE LEAKING SAMPLE PROBE AFTER SEEING HIGH AND LOW RESULTS ON VARIOUS CARTRIDGE CHEMISTRIES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED SEVERAL HARDWARE COMPONENTS. OTHER CARTRIDGE CHEMISTRIES COULD BE IMPACTED UPON RECUR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING INCORRECT RESULTS FOR GLUCOSE (GLUC), MAGNESIUM (MG) AND A LIPID PANEL GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. THE RESULTS WERE REPORTED OUT OF THE LAB. RESULTS WERE REQUESTED BY BCI, BUT NOT SUPPLIED BY THE CUSTOMER. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1