BEUDAMED
    FDA Adverse Event Summary report: N

    AU643-02 CHEMISTRY ANALYZER

    MDR report key: 2042723 · Received April 6, 2011

    Report

    Report Number
    2050012-2011-00947
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FAXED MSDS FOR WASH SOLUTION. BCI MADE 6 ATTEMPTS TO CONTACT THE CUSTOMER TO FOLLOW UP WITH THE OPERATOR, BUT NO FURTHER CONTACT COULD BE MADE SINCE (B)(6) 2011. 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 SPLASH OCCURRED WHILE PERFORMING WEEKLY MAINTENANCE ON AU643-02E CHEMISTRY ANALYZER. THE MAINTENANCE TECHNICIAN GOT SPLASHED IN THE EYE WITH SOLUTION CAME OUT OF THE TUBING FROM THE WASH NOZZLE. THE TECHNICIAN WAS WEARING GLOVES BUT NOT GOGGLES. AS THE TECHNICIAN WAS TAKING WASH NOZZLE OFF, FLUID ON THE TIPS SPAYED UP. THE CUSTOMER FOLLOWED THE FACILITY'S BIOHAZARD AND CHEMICAL EXPOSURE PLAN. THE EFFECT TO THE USER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU643-02 CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other