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U.S. Department of Health and Human Services

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

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TECAN SCHWEIZ AG FREEDOM EVO-2 200; PIPETTING STATION FOR CLINICAL USE Back to Search Results
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.
 
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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 Key4611627
MDR Text Key5657759
Report Number3003402518-2015-00001
Device Sequence Number1
Product Code JQW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number30020020
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/10/2015
Initial Date FDA Received03/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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