BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2720155 · Received August 29, 2012

    Report

    Report Number
    1061932-2012-02350
    Event Type
    Injury
    Date Received
    August 29, 2012
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE OPERATION OF THE INSTRUMENT INCLUDING THE SINGLE TUBE PRESENTATION AND FOUND THE INSTRUMENT TO BE PERFORMING WITHIN SPECIFICATIONS. MULTIPLE SAMPLES WERE RUN WITH NO ISSUES. NO OTHER OPERATOR HAS EXPERIENCED A SIMILAR ISSUE. PER FACILITY HEMATOLOGY SUPERVISOR INVESTIGATING THE EVENT, THE EVENT WAS LIKELY DUE TO OPERATOR ERROR. PER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM INSTRUCTIONS FOR USE, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. FIELD SERVICE ENGINEER (FSE) REPORTED THAT A CUSTOMER WAS SPRAYED IN THE FACE AND EYES WITH A SMALL AMOUNT OF BLOOD WHILE REMOVING THE CAP TO PROCESS A PATIENT SAMPLE ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM IN SINGLE TUBE PRESENTATION. THE HEALTHCARE WORKER INTERFACING WITH THE INSTRUMENT WAS WEARING A LABORATORY COAT AND GLOVES BUT WAS NOT WEARING EYE PROTECTION AS INSTRUCTED PER BECKMAN COULTER INC. INSTRUCTIONS FOR USE. THE HEALTHCARE WORKER WENT TO THE EMPLOYEE HEALTH DEPARTMENT AT THE SAME FACILITY WHERE THEIR EYES WERE FLUSHED. THEY WERE GIVEN NON-PRESCRIPTION EYE DROPS, AND THEIR BLOOD WAS DRAWN PER FACILITY EXPOSURE PROTOCOL. INITIAL BASELINE BLOOD WORK PERFORMED ON THE EXPOSED HEALTHCARE WORKER RECOVERED AS NEGATIVE FOR ALL TESTING. TESTING ON THE PATIENT SPECIMEN WAS ALSO PERFORMED AND WAS NEGATIVE AND THE PATIENT ASSOCIATED WITH THE SPECIMEN WAS NOT KNOWN TO HAVE AN INFECTIOUS DISEASE. THERE IS A RISK MANAGEMENT PLAN AT THE FACILITY AND THE MATERIAL SAFETY DATA SHEET WAS NOT REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention