BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1634879 · Received March 18, 2010

    Report

    Report Number
    2050012-2010-00122
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 9, 2010
    Report Date
    March 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEFORE THE EVENT, THE ISE SYSTEM WAS CALIBRATED AND SODIUM QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. PRE-ANALYTICAL SAMPLE HANDLING WAS DISCUSSED WITH CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE DECONTAMINATED THE ISE SYSTEM 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 FOR MULTIPLE SAMPLES. THE INITIAL RESULTS IN THE RANGE OF 122-130 MMOL/L WERE REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLES WERE RE-TESTED AND REPEATED SODIUM RESULTS WERE HIGHER THAN ON THE INITIAL RUN. AMENDED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT AFFECTED.

    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