MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-26 for FREEDOM EVO 30020020 manufactured by Tecan Schweiz Ag.
[44477156]
A tecan field service engineer (fse) was on site on (b)(6) 2016 to check the instrument. The fse inspected the device and identified that the tension on the y-belt on the pipetting arm is less than required. The belt appeared worn and beginning to fray. Fse replaced the affected arm. The issue has since not reoccurred on the new arm. The complaint did not lead to death or serious deterioration of health of a user or a patient. The device is used for research use only and not for clinical diagnostic testing. No results were released to the physician or the patient. No similar reports of faulty pipetting due to loose y-belt on the pipetting arm were previously reported to tecan. The manufacturer's investigation to determine the root cause is ongoing. A follow up report will be provided to the fda when further information is known.
Patient Sequence No: 1, Text Type: N, H10
[44477157]
The customer reported to tecan on (b)(6) 2016 that the pipetting arm on tecan freedom evo instrument pipetted into a wrong well of a 384 microplate. The complaint did not lead to death or serious deterioration of health of a user or a patient. The instrument is used for research use only and not for clinical diagnostic testing. No results were released to the physician or the patient.
Patient Sequence No: 1, Text Type: D, B5
[60339172]
Root cause investigation included: review of service event where arm was replaced on (b)(6) 2016; review of service and complaint history for the instrument; review of the manufacturing history of the arm and associated repair records; review of usage history vs. Module life-expectancy; attempts to reproduce the problem observed. Conclusions: tecan was unable to reproduce the issue when testing an arm with y belt tension out of specification. Lifetime results for the y belt were reviewed and found acceptable with no issues noted. Internal tests were conducted to evaluate and try to reproduce the stress profile of the y-belt. The maintenance and manufacturing history were found acceptable and within specification. This issue is considered an isolated event. A review of complaint data indicates no similar occurrences of pipetting issues due to y-belt. Tecan will continue to monitor complaint trends. The customer has no additional occurrences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2016-00002 |
| MDR Report Key | 5608280 |
| Date Received | 2016-04-26 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-03-28 |
| Date Mfgr Received | 2016-03-28 |
| Date Added to Maude | 2016-04-26 |
| 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 | MRS. BARBARA JERONCIC |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 1449228487 |
| 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 |
| Generic Name | FREEDOM EVO 200 |
| Product Code | JQW |
| Date Received | 2016-04-26 |
| Model Number | 30020020 |
| 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 | SEESTRASSE 103 MAENNEDORF, 8708 SZ 8708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-26 |