BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1980915 · Received February 7, 2011

    Report

    Report Number
    2050012-2011-00394
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 9, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO REPLACE THE SAMPLE PROBE SYRINGE PLUNGER, BUT IT DID NOT RESOLVE THE ISSUE. THE SERVICE VISITED ON (B)(4) 2011. PRIOR TO SERVICE ARRIVAL, THE CUSTOMER CHANGED THE SAMPLE PROBE AND WASH COLLAR. THE FIELD SERVICE ENGINEER (FSE) PRIMED THE PROBE TO IDENTIFY THE LEAK SOURCE, AND NOTED SMALL AMOUNT OF FLUID AT THE TIP OF PROBE WHEN IN STANDBY. THE FSE REPLACED T-VALVES ON REAGENT SYRINGE AND REAGENT SYRINGE TUBING TO PROBE. THE FSE PRIMED THE PROBE AND OBSERVED NO FLUID IN COLLAR AT STANDBY. THE LEAKING ISSUE WAS RESOLVED. THE FSE COMPLETED PREVENTIVE MAINTENANCE, CALIBRATED THE INSTRUMENT AND RAN QC.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER WAS HAVING PROBLEMS WITH CALIBRATION AND A LEAK ON SAMPLE PROBE AFTER REPLACING THE COLLAR WASH AND THE SAMPLE PROBE. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1