BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 4191480 · Received October 22, 2014

    Report

    Report Number
    2050012-2014-00474
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER HOTLINE SUPPORT ASSISTED CUSTOMER TO TROUBLESHOOT OVER THE PHONE AND FOUND THE LEAK WAS FROM REAGENT PROBE B. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND CONFIRMED THE LEAK FROM REAGENT PROBE B. THE LEAK WAS DETERMINED TO BE EITHER DEIONIZED (DI) WATER OR DILUTED WASH SOLUTION. THE FSE REPLACED THE REAGENT PROBE B WASH COLLAR VALVE (SOLENOID VALVE) TO RESOLVE THE ISSUE, NO FURTHER LEAKING WAS OBSERVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HER UNICEL DXC 800 PRO INSTRUMENT HAD FLUID LEAKING INTO THE REAGENT COMPARTMENT. CUSTOMER REPORTED THE LEAK WAS CONTAINED IN THE INSTRUMENT AND DIDN'T LEAK TO THE FLOOR. CUSTOMER REPORTED NO ERRONEOUS RESULTS HAVE BEEN GENERATED. CUSTOMER REPORTED NO DIRECT EXPOSURE OF THE LEAK. CUSTOMER WAS WEARING GLOVES, LABORATORY COAT, AND EYE PROTECTION GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671137 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