MAUDE Adverse Event Report: TECAN SCHWEIZ AG FREEDOM EVO-2 200; STATION, PIPETTING ND DILUTING FOR CLINICAL USE

Model Number 10641541

Device Problems Fail-Safe Design Failure (1222); Inadequate User Interface (2958)

Patient Problem Abrasion (1689)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

A tecan field service engineer (fse) was on site on april 11th, 2016 to check the instrument.The door locks have not been disabled or manipulated in any way.They are tested at least every 6 months for this customer during the 2 preventive maintenances performed each year.Customer verified that the door locks were engaged and the panel was closed when the injury occured.The fse ran the safety tests when on site on apr 11th, 2016 on the freedom evo in s&s and they passed.Results are available.No failure was found with the instrument.The instrument performed as intended.The instrument did not malfunction.User admitted they reached under the shield while the instrument was in operation.The labeling of the instrument warns against not reaching into the instrument when the instrument is running.Additionally, front shield and door locks are designed to engage and prevent access when instrument is operating.The laboratory confirmed that they train all technicians not to reach inside an instrument and even have stickers on the shields as a reminder.This report is filed as similar occurences have happened resulting in more serious injuries.

Event Description

Tecan was informed that a laboratory employee was injured reaching into the instrument freedom evo 200 while the instrument was running.The date of the injury is (b)(6) 2016.The event was reported to tecan on (b)(6) 2016 with a request to evaluate the possibility to change the front door (shield) with more restrictive one.The injury was described as a puncture wound (more like an abrasion) on the hand and it was considered by the laboratory as a minor injury.Nothing was done for treatment other than precautionary antibiotics.The laboratory was running patient samples at the time of the incident.The front panel was closed and the door locks were engaged.

• Brand Name: FREEDOM EVO-2 200
• Type of Device: STATION, PIPETTING ND DILUTING FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, 8708 ; SZ 8708
• Manufacturer (Section G): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, 8708 ; SZ 8708
• Manufacturer Contact: claudia solimeo meneghisse ; seestrasse 103; maennedorf, zuerich 8708 ; SZ 8708 ; 1449228992
• MDR Report Key: 5604381
• MDR Text Key: 43510057
• Report Number: 3003402518-2016-00001
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 10641541
• Device Catalogue Number: 10150791
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other