BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2143678 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02761
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 29, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN ONCE A DAY AND WAS WITHIN THE LAB'S ESTABLISHED RANGES ON THE DAY OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE, CLEANED THE BUILDUP FROM THE FLOWCELL AND REPLACED THE CO2 MEMBRANE AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO FALSE LOW RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. WHEN THE LOW ANION GAPS WERE NOTICED, THE SAMPLES WERE RUN 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 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1