BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2003423 · Received March 1, 2011

    Report

    Report Number
    2050012-2011-00594
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO INSPECT THE REAGENT SYRINGE FOR LEAKS AND BUBBLES, AND TO TIGHTEN ALL REAGENT PROBES AND SYRINGE FITTINGS. THE CTS ALSO INSTRUCTED THE CUSTOMER TO REPLACE REAGENT SYRINGE PLUNGER BUT THE ISSUE WAS NOT RESOLVED. BCI FIELD SERVICE ENGINEER VISITED THE SITE ON (B)(4) 2011. THE FSE REPLACED AND CALIBRATED REAGENT PROBE A LEVEL SENSE BEAD TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THAT THE INSTRUMENT WAS GIVING LEVEL SENSE ERROR WITH REAGENT PROBE A AND THE REAGENT TRAY WELL FILLED WITH LIQUID. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1