BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO-2 200 MCA

    MDR report key: 3784287 · Received April 24, 2014

    Report

    Report Number
    3003402518-2014-00002
    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
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABORATORY CONTACTED TECAN BY EMAIL ON (B)(4) 2014 FOR A COPY OF THE INSTRUMENT OPERATOR'S MANUAL STATING THAT AN INJURY HAD OCCURRED. UPON PHONE FOLLOW UP, THE LABORATORY INDICATED THAT AN EMPLOYEE WAS INJURED WHILE REACHING INTO THE INSTRUMENT AS IT WAS RUNNING TO SWITCH OUT A PLATE. THE EMPLOYEE'S HAND WAS STAB BY A TIP. THERE WAS NO ADDITIONAL INFORMATION ON THE EXTENT OF INJURIES; HOWEVER, MEDICAL ATTENTION WAS SOUGHT. THE DOOR LOCKS WERE DISABLED BY PLACING TAPE OVER THE DOOR LOCK MECHANISM. THE LABORATORY INDICATED THAT THE INSTRUMENT DOOR LOCKS HAD BEEN DISABLED FOR A LONG TIME POSSIBLY BACK TO INSTALL. TECAN'S LABELING WARNS AGAINST ACCESSING THE INSTRUMENT WHILE IN OPERATION AND THE DOOR LOCKS ARE DESIGNED TO PREVENT ACCESS WITHOUT PAUSING THE INSTRUMENT. THE LABORATORY RE-ENGAGED DOOR LOCKS AND SENT AN INTERNAL SAFETY ALERT TO ENSURE ALL OTHER INSTRUMENTS WERE CHECKED FOR PROPER GUARDING.

    Description of Event or Problem · 1

    A LABORATORY EMPLOYEE REPORTED AN 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 AND D PURPOSES. THE LABORATORY STATED THAT THE DOOR LOCKS HAD 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
    248849 EVO-2 200 MCA PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other