BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2024346 · Received March 18, 2011

    Report

    Report Number
    2050012-2011-00761
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER TO TROUBLESHOOT AND RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT BEFORE TROUBLESHOOTING. CTS ADVISED CUSTOMER TO TREAT TONER AS A POTENTIAL BIOHAZARD. THE CUSTOMER/ LABORATORY HAS BIOHAZARD SPILL PROTOCOL. CTS RECOMMENDED CUSTOMER LOG ON TO THE (B)(4) WEBSITE AND REVIEW THE MSDS FOR THE TONER. CTS SENT A REPLACEMENT PRINTER OVERNIGHT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER'S (B)(4) PRINTER DRUM LEAKING TONER. THE LEAKING HARDWARE MAY CAUSE INCORRECT RESULTS OR OPERATOR EXPOSURE TO CHEMICALS OR BIOHAZARDS UPON REOCCURRENCE. NO FUMES WERE PRODUCED AND CUSTOMER WAS NOT HARMED NOR NEEDED MEDICAL TREATMENT FROM EXPOSURE TO THE TONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC600P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1