BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2210840 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04492
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE CUSTOMER TO USE PPE BEFORE TROUBLESHOOTING THE INSTRUMENT. THE CUSTOMER CHECKED THE CUVETTE WASH STATION, BUT NO LEAK WAS OBSERVED. THE CTS VERIFIED THAT SYRINGE MAINTENANCE WAS IN DATE: 45 DAYS WERE LEFT. THE CUSTOMER FOUND CC REAGENT PROBE B WAS LEAKING FROM THE WASH COLLAR AND THE FITTING ON TOP OF THE REAGENT PROBE WAS LOOSE. THE CUSTOMER ALSO REPORTED THAT THE REAGENT SYRINGE WAS LOOSE BUT NOT LEAKING. THE CUSTOMER TIGHTENED IT. THE CUSTOMER CLEANED AND DRIED REAGENT PROBE B. THE CTS ADVISED THE CUSTOMER TO PRIME THE REAGENT DELIVERY SYSTEM. NO ERRORS OR LEAKS WERE OBSERVED. THE CTS ADVISED THE CUSTOMER TO PERFORM WASH ALL CUVETTES, AND THE CUSTOMER WAS TO MONITOR THE INSTRUMENT AND CALL THE CTS IF PROBLEM CONTINUED. THE CUSTOMER CALLED BACK ON THE SAME DAY TO REPORT THAT REAGENT PROBE B WAS STILL DRIPPING AFTER TIGHTENING THE TUBING ON TOP. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT. THE FSE REPLACED NC PROBE VALVE AND AB VALVE. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. THE FSE STATED THAT THE AB VALVE WAS THE ROOT CAUSE OF THE PROBE LEAKING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ERROR MESSAGES OF "CUVETTE NOT DRY BEFORE REAGENT DISPENSE" WERE RECEIVED ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER ALSO REPORTED THAT CARTRIDGE CHEMISTRY (CC) QC HAD BEEN ERRATIC. THE CUSTOMER FOUND CC REAGENT PROBE B WAS LEAKING. MSDS WAS REVIEWED, AND THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1