MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-25 for FREEDOM EVO-2 200 10641541 10150791 manufactured by Tecan Schweiz Ag.
[43510057]
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.
Patient Sequence No: 1, Text Type: N, H10
[43510058]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003402518-2016-00001 |
| MDR Report Key | 5604381 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-25 |
| Date of Report | 2016-04-25 |
| Date of Event | 2016-04-08 |
| Date Mfgr Received | 2016-04-08 |
| Device Manufacturer Date | 2005-11-25 |
| Date Added to Maude | 2016-04-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CLAUDIA SOLIMEO MENEGHISSE |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, ZUERICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 1449228992 |
| Manufacturer G1 | TECAN SCHWEIZ AG |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8708 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO-2 200 |
| Generic Name | STATION, PIPETTING ND DILUTING FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2016-04-25 |
| Model Number | 10641541 |
| Catalog Number | 10150791 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ AG |
| Manufacturer Address | SEESTRASSE 103 MAENNEDORF, 8708 SZ 8708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-25 |