BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2235860 · Received September 7, 2011

    Report

    Report Number
    2050012-2011-05099
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS EXHIBITING ERRATIC RECOVERY. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE MODULAR CHEMISTRY (MC) 3-WAY VALVE AND SYRINGE TIP AS WELL AS REPLACED THE NA MEASURING ELECTRODE AND VERIFIED PERFORMANCE. THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING FALSE LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT IN THE LABORATORY AND THOSE RESULTS WERE REPORTED OUT. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1