BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 3052964 · Received April 11, 2013

    Report

    Report Number
    2050012-2013-00250
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE ON (B)(4) 2013. THE FSE REPLACED WASH COLLARS, CUVETTE WASH PROBES, AND MIXER PADDLES TO RESOLVE THE ISSUE. THE FSE PERFORMED CARRYOVER AND PRECISION TESTS AND OBTAINED ACCEPTABLE RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM GENERATED ERRONEOUSLY ELEVATED TRIGLYCERIDE (TG) PATIENT RESULTS. REPEAT TESTING PRODUCED LOWER RESULTS. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT THE CUSTOMER INDICATED THAT THERE HAD BEEN NO REPORT OF PATIENT CONSEQUENCES. THE CUSTOMER PROVIDED A TOTAL OF 117 PATIENTS' RESULTS OBTAINED DURING THE PERIOD OF (B)(6) 2013. THIS REPORT DOCUMENTS THE PATIENT RESULTS OBTAINED FOR 62 PATIENTS ON (B)(6) 2013. THE PATIENT RESULTS OBTAINED ON OTHER DAYS OF THE REPORTED PERIOD ARE DOCUMENTED IN THE BELOW LISTED REPORTS: 2050012-2013-00238, 2050012-2013-00239, 2050012-2013-00249.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156225 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1