BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2232163 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04756
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER RESOLVED THE ISSUE. THE CUSTOMER CONTINUES TO MONITOR THE INSTRUMENT FOR ANY FURTHER ISSUES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER WAS GENERATING "LOW PRESSURE - LOW" ERRORS AFTER CHANGING WASH CONCENTRATE. THE CUSTOMER STOPPED THE INSTRUMENT AND RESEATED THE WASH CONCENTRATE CAP; WASH CONCENTRATE WAS SPILLED ON THE FLOOR. THE CUSTOMER STOPPED THE INSTRUMENT AND ADJUSTED THE 10 PSI REGULATOR TO 10.3. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1