BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 680I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 3834203 · Received May 28, 2014

    Report

    Report Number
    2050012-2014-00261
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    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

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE CONFIRMED A LEAK FROM THE CAP PIERCER BLADE WASH. THE FSE REPLACED THE CAP PIERCER THREE-WAY SOLENOID WASTE VALVE TO CORRECT THE LEAK. BEC INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CAP PIERCER OF A UNICEL DXC 680I SYNCHRON ACCESS CLINICAL SYSTEM WAS LEAKING ONTO SAMPLE TUBE CAPS. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, GLASSES, AND A LAB COAT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312806 UNICEL DXC 680I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1