BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1993884 · Received February 16, 2011

    Report

    Report Number
    2050012-2011-00461
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAK WAS CONTAINED TO THE INSTRUMENT COVERS. BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND FOUND OUT THAT THE CUSTOMER DID NOT PUT TOGETHER THE PROBES PROPERLY AFTER FLUSHING THEM FOR MAINTENANCE, WHICH CAUSED THE LEAK. THE PROBLEM WAS CORRECTED AND LEAK WAS CLEANED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LEAKAGE ON UNICEL DXC 600 SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER PERFORMED MAINTENANCE AND WAS GETTING A SAMPLE MIXER MOTION ERROR AND THE UNIT WOULD NOT HOME. NO ONE WAS HARMED AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1