BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO-2 200

    MDR report key: 3795499 · Received April 23, 2014

    Report

    Report Number
    1037985-2014-00001
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 23, 2014
    Manufacturer
    TECAN SCHWEIZ
    Product Code
    JQW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A LAB EMPLOYEE WAS INJURED REACHING INTO THE FREEDOM EVO 200 INSTRUMENT WHILE INSTRUMENT WAS RUNNING ON (B)(6) 2014. THE EVENT WAS REPORTED TO TECAN ON (B)(6) 2014 WITH A REQUEST TO RE-ENGAGE THE DOOR LOCKS. THE EMPLOYEE RECEIVED A PUNCTURE TO HIS FINGER FROM THE FIXED TIP DISPENSING NEEDLES ON THE LIQUID HANDLING ARM. THE FINGER BLED AND EMPLOYEE WAS INITIALLY TREATED BY A CORPORATE NURSE. AN INTERNAL SAFETY INCIDENT WAS FILED. NO ADD'L INFO REGARDING TREATMENT OR THE SERIOUSNESS OF INJURY WAS SHARED WITH TECAN. THE INSTRUMENT WAS PROCESSING PT SAMPLES AT THE TIME OF THE INCIDENT. THE DOOR LOCKS WERE DISABLES ON THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244758 EVO-2 200 PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other