BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 2033003 · Received March 30, 2011

    Report

    Report Number
    2050012-2011-00895
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DISABLED THE MODULE UNTIL SERVICE ARRIVED. A BCI FIELD SERVICE ENGINEER WAS DISPATCHED; HOWEVER, UPON ARRIVAL THE BUN MODULE WAS OPERATING WITHOUT ISSUE. FSE DID NOT NOTE ANY BUN OVERFLOW.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT BUN CUP OVERFLOW ON THE SYNCHRON LX 20 PRO CLINICAL SYSTEM. THE CUSTOMER NOTICED THE OVERFLOW WHILE PERFORMING MAINTENANCE ON THE INSTRUMENT. THE BUN FILLED PROPERLY; HOWEVER, CUP WILL NOT DRAIN. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX-20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1