BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 1971276 · Received January 26, 2011

    Report

    Report Number
    2050012-2011-00214
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RESULTS WERE WITHIN RANGE PRIOR TO AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE GLUCOSE STIRRER MOTOR, REAGENT TUBING LINES AND REAGENT SYRINGE. ALTHOUGH HARDWARE WAS ADDRESSED, A CLEAR ROOT CAUSE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A DIFFERENCE IN GLUCOSE MODULAR DUPLICATE RESULT ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER UNITS. THE CUSTOMER RUNS GLUM PATIENTS IN DUPLICATE ON THE INSTRUMENT AND THEY ARE NOT MATCHING. THE RESULT WAS NOT REPORTED OUT OF LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1