BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON SYSTEM

    MDR report key: 3885140 · Received June 19, 2014

    Report

    Report Number
    2050012-2014-00314
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) OFFERED TO SEND A FIELD SERVICE ENGINEER (FSE) TO REPAIR THE INSTRUMENT. THE CUSTOMER WAS IN THE PROCESS OF BRINGING NEW INSTRUMENTS INTO THE LABORATORY AND DECLINED REPAIR AS THIS INSTRUMENT WOULD BE TAKEN OUT OF SERVICE. THE INSTRUMENT WAS REMOVED FROM THE LABORATORY.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM A REAGENT PROBE ONTO THE REAGENT PROBE DRIP TRAY OF A UNICEL DXC 600 PRO SYNCHRON SYSTEM. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE CUSTOMER STATED THAT THE LEAK WOULD OCCUR AFTER PRIMING THE REAGENT PROBE. THE OPERATOR WAS WEARING A LAB COAT, GLOVES, AND PROTECTIVE EYEWEAR. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY AS A RESULT OF THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THE LEAK. A REMOTE REVIEW OF THE INSTRUMENT SHOWED THAT THE INSTRUMENT DID NOT GENERATE ANY FLAGS OR ERROR MESSAGES TO ALERT THE CUSTOMER TO A SYSTEM ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360703 UNICEL DXC 600 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1