BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM

    MDR report key: 1696824 · Received May 24, 2010

    Report

    Report Number
    2050012-2010-00269
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    April 29, 2010
    Report Date
    May 24, 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
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM IS CALIBRATED EVERY 12 HOURS FOLLOWED BY A QC RUN. THE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE ISE SYSTEM WAS RECALIBRATED. NO ADDITIONAL CALLS HAVE BEEN MADE IN REGARDS TO THIS EVENT. A CLEAR ROOT CAUSE HAS NOT BEEN IDENTIFIED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW CHLORIDE (CL) AND SODIUM RESULTS, WHICH WERE GENERATED BY UNICEL DXC 800 PRO CHEMISTRY ANALYZER. PATIENT SAMPLES WERE REPEATED AND THE NA AND CL RESULTS WERE HIGHER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIAN. PATIENT TREATMENT WAS NOT AFFECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1