BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 3915067 · Received July 6, 2014

    Report

    Report Number
    2050012-2014-00334
    Event Type
    Malfunction
    Date Received
    July 6, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED A LEAK AT REAGENT PROBE B; THE CAUSE OF THE LEAK WAS ASSIGNED TO THE COLLAR WASH VALVE. THE FSE REPLACED THE VALVE TO CORRECT THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER HOTLINE SUPPORT THAT THEIR UNICEL DXC 800 PRO SYNCHRON SYSTEM WAS LEAKING FROM THE REAGENT PROBE B COLLAR WASH. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE OPERATOR WORE GLOVES AND A LAB COAT WHILE OPERATING THE INSTRUMENT. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393032 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