BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2140124 · Received June 25, 2011

    Report

    Report Number
    2050012-2011-02629
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CTS (CUSTOMER TECHNICAL SUPPORT) HAD THE CUSTOMER REMOVE THE COVERS TO THE WASH STATION AND THE REACTION WHEEL. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND FOUND THAT 2 PROBES ON THE WASH STATION WERE NOT ASPIRATING WELL AND THE CUVETTES WERE OVERFLOWING OCCASIONALLY. FSE REPLACED THE PROBES AND NO FURTHER LEAK WAS OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING LIQUID UNDERNEATH THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WHICH APPEARED TO BE WASTE LIQUID. THE CUSTOMER COULD NOT LOCATE THE EXACT SOURCE OF THE LEAK. THE CUSTOMER ALSO INDICATED THE INSTRUMENT WAS GIVING 10 CUVETTES FAILED THE H2O ERRORS. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1