BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1962210 · Received January 17, 2011

    Report

    Report Number
    2050012-2011-00135
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING (TS). THE CUSTOMER RE-CHECKED PLUNGER AND BARREL SEATING; THE PLUNGER WAS NOT OPERATING PROPERLY. THE CUSTOMER THEN REPLACED THE SYRINGE ASSEMBLY, WHICH RESOLVED THE ISSUE AS THE PLUNGER BEGAN TO OPERATE PROPERLY. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT FLUID WAS LEAKING FROM THE CHEMISTRY CARTRIDGE (CC) SAMPLE PROBE LOCATED IN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER ALSO STATED THAT A SAMPLE SYRINGE MOTION ERROR OCCURRED AFTER REPLACING THE SYRINGE PLUNGERS. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1