MAUDE Adverse Event Report: TECAN SCHWEIZ EVO-2 200; PIPETTING STATION FOR CLINICAL USE

Catalog Number 10641202

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Injury (2348); Needle Stick/Puncture (2462)

Event Date 03/28/2014

Event Type  Injury  

Event Description

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.

• Brand Name: EVO-2 200
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ; maennedorf; zuerich ; SZ
• Manufacturer (Section G): TECAN U.S.; 4022 stirrup creek rd.; research triangle park NC 27709
• Manufacturer Contact: 4022 stirrup creek rd.; research triangle park, NC 27709
• MDR Report Key: 3795499
• MDR Text Key: 18933301
• Report Number: 1037985-2014-00001
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10641202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2014
• Distributor Facility Aware Date: 04/02/2014
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 04/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other