BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1938239 · Received December 27, 2010

    Report

    Report Number
    2050012-2010-01706
    Event Type
    Injury
    Date Received
    December 27, 2010
    Date of Event
    August 10, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS PROCEDURE FOR HANDLING A CHEMICAL SPILL AND IMPLEMENTED PER POLICY. THE CUSTOMER FELT IT WAS AN INTERNAL ISSUE AS THE LAB TECH WAS NOT FOLLOWING CORRECT PROCEDURE BY NOT WEARING PERSONAL PROTECTIVE EQUIPMENT, AND DID NOT REPORT THE INCIDENT TO BCI UNTIL THE FSE DISCOVERED IT DURING AN ONSITE VISIT.

    Description of Event or Problem · 1

    DURING AN ONSITE VISIT, AN FIELD SERVICE ENGINEER (FSE) FROM BECKMAN COULTER, INC (BCI) DISCOVERED THAT THERE WAS AN INCIDENT OF CHEMICAL EXPOSURE IN THE LABORATORY. A LABORATORY TECHNICIAN WAS INVESTIGATING A SOURCE OF LEAK IN THE HYDRO PNEUMATIC AREA OF UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER, AND WAS UNAWARE THAT THE POTASSIUM HYDROXIDE (WASH CONCENTRATE II) SOLUTION HAD BEEN SPILLED ONTO THE LATCH THAT ALLOWS ACCESS TO THE HYDRO PNEUMATIC COMPONENTS. THE LAB TECH WAS NOT WEARING GLOVES WHEN CAME IN CONTACT WITH POTASSIUM HYDROXIDE SOLUTION, WHICH CAUSED CHEMICAL BURNS ON SEVERAL FINGERS. THE LAB TECH WAS EVALUATED BY THE EMERGENCY DEPARTMENT AND RELEASED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other