BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2091508 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01593
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND HAD CUSTOMER RESEAT THE SENSOR. THE CUSTOMER RECALIBRATED AND IT PASSED. CTS FOLLOWED UP WITH CUSTOMER ON 04/22/2011 AND THE ISSUE HAD BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEAK THAT WAS OBSERVED IN THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER HAD REPLACED THE GLUCOSE ELECTRODE ON THE WEEKEND PRIOR TO THE EVENT, CALIBRATED THE SENSOR, CALIBRATED GLUCOSE AND QC PASSED. WHEN THE CUSTOMER RETURNED TO THE LABORATORY ON MONDAY, THE GLUCOSE MODULE WAS DISABLED AND FOUND A SMALL LEAK ON THE SIDE OF THE MODULE. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1