BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1657083 · Received April 13, 2010

    Report

    Report Number
    2050012-2010-00174
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 17, 2010
    Report Date
    April 12, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS CALIBRATED EVERY 24 HOURS FOLLOWED BY A QC RUN. PRIOR TO THIS EVENT, THE ISE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES.A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: A) THE FSE REPLACED THE RATIO PUMP PISTON AND SEALS.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 INTERMITTENTLY, ERRONEOUSLY HIGH SODIUM (NA) AND CHLORIDE RESULTS GENERATED BY THE UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS.THE SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT AND LOWER RESULTS WERE OBTAINED. THESE RESULTS WERE REPORTED OUT OF THE LAB.THERE WAS NO AFFECT TO PATIENT TREATMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB.

    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