BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 3990333 · Received August 7, 2014

    Report

    Report Number
    2050012-2014-00363
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 6, 2013
    Report Date
    July 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE CONFIRMED A LEAK FROM THE REAGENT PROBE A COLLAR WASH AND REPLACED THE REAGENT PROBE A COLLAR WASH VALVE TO CORRECT THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) HOTLINE SUPPORT THAT, OVER THE PERIOD OF A WEEK, REAGENT PROBE A ON THEIR UNICEL DXC 800 PRO SYNCHRON SYSTEM DRIPPED 1 OR 2 DROPS OF FLUID WHEN WASHED. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THE OPERATOR WORE A LABORATORY COAT AND GLOVES WHILE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464411 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1