BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO-2 200 MCA

    MDR report key: 3783536 · Received April 24, 2014

    Report

    Report Number
    1037985-2014-00002
    Event Type
    Injury
    Date Received
    April 24, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LABORATORY EMPLOYEE WAS INJURED WHILE OPERATING THE FREEDOM EVO INSTRUMENT. THE DOOR LOCKS WERE DISABLED AND THE OPERATOR REACHED INTO THE INSTRUMENT DURING OPERATION. THE OPERATOR'S FINGER WAS PUNCTURED AND THE OPERATOR DID RECEIVE MEDICAL TREATMENT. THE EXTENT OF TREATMENT OR THE SERIOUSNESS OF THE INJURY WAS NOT SHARED WITH TECAN. THE INSTRUMENT WAS BEING USED FOR R&D PURPOSES. THE LABORATORY STATED THAT THE DOOR LOCKS HAS BEEN DISABLED FOR A LONG TIME AND HE DID NOT KNOW WHO DISABLED THEM. THE LABORATORY SENT A COPY OF THEIR INTERNAL SAFETY REPORT TO TECAN INDICATING THE DOOR LOCKS WERE RE-ENGAGED AND PROHIBITING INTENTIONALLY DISABLING EQUIPMENT GUARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249501 EVO-2 200 MCA PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other