BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO-2 200

    MDR report key: 3866641 · Received April 23, 2014

    Report

    Report Number
    3003402518-2014-00001
    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
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TECAN FSE WAS ON SITE ON (B)(4) 2014 AT LABORATORY FOR AN UNRELATED ISSUE AND WAS INFORMED THAT A LAB EMPLOYEE WAS INJURED BY THE EVO 200 ROBOT'S LIQUID HANDLING ARM WHEN REACHING INTO THE INSTRUMENT DURING OPERATION. THE INSTRUMENT OPERATOR'S FINGER WAS PUNCTURED BY THE FIXED TIP DISPENSING NEEDLES ON THE LIQUID HANDLING ARM. THE LABORATORY WAS RUNNING PT SAMPLES AT THE TIME OF THE INCIDENT POTENTIALLY RESULTING IN BIOHAZARD EXPOSURE TO THE WOUND AREA. THE DOOR LOCKS ON THE INSTRUMENT WERE DISABLED ALLOWING FOR THE OPERATOR TO REACH IN WITHOUT HAVING TO PAUSE THE INSTRUMENT. THE DOOR LOCKS HAD BEEN PREVIOUSLY DISABLED. TECAN'S LABELING WARNS AGAINST ACCESSING THE INSTRUMENT WHILE IN OPERATION AND THE DOOR LOCKS ARE DESIGNED TO PROHIBIT ACCESS WITHOUT PAUSING THE INSTRUMENT. A TECAN FIELD SERVICE ENGINEER WAS DISPATCHED TO RECONNECT THE DOOR LOCKS AND TEST INSTRUMENT TO ENSURE IT PASSED ALL SAFETY TESTS.

    Description of Event or Problem · 1

    A LABORATORY 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 DISABLED ON THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245193 EVO-2 200 PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ

    Patients

    Seq Age Sex Outcome Treatment
    1