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

Catalog Number 30020020

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

Customer reported a doorlock error where the door of the instrument freedom evo-2 was open and the instrument continued to move the pipetting arms.This happened after pressing the "pause" button on the instrument freedom evo-2 and clicking "continue" on the touch tools user prompt, the door locks of the instrument freedom evo 200 were unlocked while the arms were still moving.The customer did not reach in to the instrument and there was no injury.According to customer information the event happened in (b)(6) 2015, but was only reported to tecan on (b)(4) 2015.

Manufacturer Narrative

A tecan field service engineer was on site on (b)(4) 2015 to review the status of the instrument.Checked functionality of door locks in setup and service.Door locks are able to be controlled via the safety panel and the door lock test passed.Complete export and software logfiles were sent to tecan experts for further investigation.Tecan could reproduce the reported error in a very specific sequence of events and has escalated the investigation to evaluate the root cause and the scope.Investigation is still ongoing and a follow up report will be sent to fda.There was no injuries for this complaint.In an abundance of caution, tecan is reporting based on the current status of investigation.

• Brand Name: FREEDOM EVO-2 200
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; maennedorf zuerich ; SZ
• Manufacturer Contact: 103 seestrasse; maennedorf zuerich 8708 ; 49228560
• MDR Report Key: 4611627
• MDR Text Key: 5657759
• Report Number: 3003402518-2015-00001
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30020020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1