BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1993881 · Received February 16, 2011

    Report

    Report Number
    2050012-2011-00462
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED FLUID LEAKED FROM THE SAMPLE PROBE. BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND DETERMINED THAT THE LEAK WAS CAUSED BY SAMPLE SYRINGE PLUNGER REPLACEMENT PERFORMED BY THE NIGHT SHIFT. THE SYSTEM WAS RUNNING AT THE TIME OF PHONE CALL TO BCI AND THE CUSTOMER DID NOT OBSERVE ADDITIONAL LEAKING FROM PROBE AND WASH COLLAR. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO FUME WAS PRODUCED. THE CUSTOMER WAS NOT HARMED AND DID NOT NEED MEDICAL TREATMENT FROM EXPOSURE TO LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1