BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1971637 · Received January 27, 2011

    Report

    Report Number
    2050012-2011-00219
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    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

    QC PRIOR TO THE EVENT WAS WITHIN LAB ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) FOUND WASH MANIFOLD WAS NOT VACUUMING PROPERLY. FSE REPLACED THE 3-WAY SOLENOID VALVE AND THE OPTICAL SWITCH. FSE TIGHTENED THE LOOSE REAGENT SYRINGE, WHICH RESOLVED THE ISSUE. ON (B)(6) 2011, THE CUSTOMER STATED THAT THE UNIT WAS OPERATING NORMALLY. ALTHOUGH HARDWARE WAS ADDRESSED A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH %HEMOGLOBIN A1C (HBA1C) RESULTS GENERATED UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM FOR THREE PATIENTS SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER WAS UNABLE TO RETRIEVE THE REPEATED RESULTS. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1