MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-12 for FREEDOM EVO-2 200 30020020 manufactured by Tecan Schweiz Ag.
[5657759]
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.
Patient Sequence No: 1, Text Type: D, B5
[13028007]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2015-00001 |
| MDR Report Key | 4611627 |
| Report Source | 07 |
| Date Received | 2015-03-12 |
| Date of Report | 2015-03-10 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-02-10 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-04-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 103 SEESTRASSE |
| Manufacturer City | MAENNEDORF ZUERICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 49228560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO-2 200 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2015-03-12 |
| Catalog Number | 30020020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ AG |
| Manufacturer Address | MAENNEDORF ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-12 |