BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1640523 · Received March 25, 2010

    Report

    Report Number
    2050012-2010-00141
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM IS CALIBRATED EVERY 8 HOURS, FOLLOWED BY A QC RUN. ON THE MORNING OF THE EVENT, THE ISE SYSTEM WAS CALIBRATED AND QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED 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 HIGH SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE HIGH RESULTS WERE DETECTED THROUGH DELTA CHECKS. NO FALSE NA RESULTS WERE REPORTED OUT OF THE LAB. THE SAMPLES IN QUESTION WERE REPEATED ON A DIFFERENT INSTRUMENT. OBTAINED RESULTS WERE 8-10MMOL/L LOWER. THESE RESULTS WERE REPORTED OUT OF THE LAB. ACTUAL RESULTS WERE NOT SUPPLIED. 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