BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2143394 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02516
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 29, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE REPLACED REAGENT SYRINGE AND T-VALVE; PERFORMED ALIGNMENTS AND RAN QC. THE FSE ORDERED A BUBBLE GENERATOR IN CASE DRIPPING RETURNED. ON (B)(4) 2011, THE LAB REPORTED TO FSE THAT THE INSTRUMENT CONTINUED TO LEAK. THE FSE RETURNED TO THE CUSTOMER'S LAB ON (B)(4) 2011 AND REPLACED THE BUBBLE GENERATOR, PRIMED THE ANALYZER AND RAN QC. CUSTOMER WAS TO CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THEY WERE EXPERIENCING ONGOING CUVETTE WATER BLANK ERRORS ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. A CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER IN TROUBLESHOOTING. CUSTOMER CHECKED CARTRIDGE CHEMISTRIES (CC) TOP END AND OBSERVED EVIDENCE OF LEAKING FROM THE REAGENT PROBES. CUSTOMER CHECKED PROBES/FITTINGS AND REAGENT SYRINGE; ALL WERE TIGHT. CUSTOMER PERFORMED QC ON THE CC SIDE WITH GOOD RESULTS. CTS GENERATED A SERVICE REQUEST TO CHECK THE INSTRUMENT. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1