BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2128292 · Received June 15, 2011

    Report

    Report Number
    2050012-2011-02352
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT (CTS) DIRECTED CUSTOMER TO FLUSH THE CC SAMPLE PROBE. PROBE CONTINUED TO LEAK AFTER PRIMING. CUSTOMER DETERMINED THE CC SAMPLE SYRINGE WAS NOT CONNECTED TO THE 3-WAY VALVE. SYRINGE WAS THEN TIGHTENED AND PRIMED WITH NO LEAKS OBSERVED. CUSTOMER WAS ADVISED TO MONITOR INSTRUMENT AND CALL CTS IF PROBLEM CONTINUED. CUSTOMER CONTACTED BCI CTS TO REPORT THAT THEY WERE UNABLE TO CALIBRATE BUN AND IGM ON CC SIDE. BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND REPLACED THE BROKEN CC SAMPLE SYRINGE AND PERFORMED CALIBRATIONS. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) OF OBTAINING CC PROBE OBSTRUCTION ERRORS FROM THE UNICEL DXC 600 PRO INSTRUMENT, AND A LEAK UNDER THE CC SAMPLE PROBE. NO REPORTS OF DEATH OR INJURY HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1