BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1628017 · Received March 10, 2010

    Report

    Report Number
    2050012-2010-00112
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM IS CALIBRATED EVERY 24 HOURS, FOLLOWED BY A QC RUN. QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. HOTLINE DID TROUBLESHOOTING WITH THE CUSTOMER TO CLEAR BUBBLES FROM THE RATIO PUMP. 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 ERRATIC SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. CUSTOMER MONITORS ANION GAPS AND ALL SAMPLES WERE RE-TESTED ON A DIFFERENT ANALYZER. NO FALSE SODIUM RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO AFFECT TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1