BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1593902 · Received February 3, 2010

    Report

    Report Number
    2050012-2010-00031
    Event Type
    Malfunction
    Date Received
    February 3, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN OCCURRENCES OF DRIFT ERRORS ON ION SELECTIVE ELECTRODE (ISE) CHEMISTRIES. QC RESULTS HAVE BEEN OUT OF RANGE. THE CUSTOMER WAS PROVIDED WITH THE TWICE-WEEKLY FLOW CELL MAINTENANCE PROCEDURE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REBUILT RATIO PUMP AND COMPLETED A PREVENTIVE MAINTENANCE (PM). A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. CUSTOMER PROVIDED AN EXAMPLE OF LOW NA RESULT. THE SPECIMEN WAS RE-TESTED AND HIGHER NA RESULT WAS GENERATED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED 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 JGS BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1