BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2891117 · Received December 31, 2012

    Report

    Report Number
    2050012-2012-01967
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) PROVIDED TELEPHONE SUPPORT TO THE CUSTOMER. CTS ADVISED THE CUSTOMER TO VISUALLY CHECK LINES 26, 15 AND THE DRAIN CONNECTION. THE CUSTOMER REPORTED THAT LINE 15 WAS KINKED. CTS GUIDED THE CUSTOMER TO UNKINK THE LINE WHICH RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE UNICEL DXC 800 SYNCHRON SYSTEM FLOW CELL DRAIN IS OVERFLOWING. THERE WERE NO REPORTS OF INJURY OR EXPOSURES TO ANY LABORATORY PERSONNEL. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1