BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 600 PRO CLINICAL SYSTEMS

    MDR report key: 1771054 · Received July 27, 2010

    Report

    Report Number
    2050012-2010-00490
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RESULTS HAVE BEEN VERY INCONSISTENT. A BCI SERVICE REPAIRED AND CLEANED THE UNIT. IN ADDITION, BCI SERVICE TIGHTENED CHEMISTRY CARTRIDGE SAMPLE SIDE T-VALVE. ROOT CAUSE APPEARS TO BE CARTRIDGE SIDE LOOSE SAMPLE T-VALVE HARDWARE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INCONSISTENT AND ERRONEOUS HIGH GLUCOSE RESULTS GENERATED BY UNICEL DXC 600 PRO CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPRODUCIBLE. PATIENT RESULTS ARE NOT AVAILABLE. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 600 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1