MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-08-29 for GENESIS FE 500 10620300 manufactured by Tecan Schweiz Ag.
[3727988]
Medical device incident notified on 07/15/2013 by customer (b)(6) infirmary ((b)(6)) to (b)(6) in of wrong results reported following contamination of the pt sample with serum from a dropped specimen. Incident happened on (b)(6) 2013, while processing samples using a fe 500 instrument. Nature of the injury was noted as distress. (b)(6) contacted tecan on 07/31/2013 to get more info about the incident. Tecan was not notified by customer of this wrong result of the complaint incident and was only aware of it once receiving the request from (b)(6). An investigation was open.
Patient Sequence No: 1, Text Type: D, B5
[11176566]
Tecan received eight complaints for this specific instrument in 2013, among which three (notification numbers (b)(4) dated 04/17/2013, (b)(4) dated 07/19/2013 and (b)(4) dated 07/30/2013) were specifically referencing dropping tubes. Complaint (b)(4) was only referencing complaint (b)(4). Root cause of the first reported complaint ((b)(4)) was use of incorrect tubes (not following tecan's recommendation, see operating medical 391400 v 3. 4). Complaint (b)(4) reported the same incident, root cause was not identified. The instrument was evaluated by a tecan service engineer on 07/23/2013 and found to be operating within specifications. The error was not reproduced. No reports of cross contamination or incorrect results were reported with these complaints. The instrument operating manual 391400 v 3. 4 describes on page 6-16 trouble shooting tips to avoid dropping of tubes. The daily maintenance procedure also recommends cleaning of the gripper, referenced in section 7. 2. 2 of the genesis fe 500 operating manual 391400 v 3. 4. At the current time tecan cannot estimate if the incident dated (b)(6) 2013 was caused due to user error/use of incorrect tubes or instrument performance. However, up to date tecan has no evidence that the instrument did not work according to its specifications. At this time point no further corrective action is planned. Tecan is in contact with the customer to further evaluate the incident dated (b)(6) 2013. When additional info is available we will amend this report. Tecan was notified on 08/27/2013 that (b)(6) closed this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2013-00006 |
| MDR Report Key | 3338714 |
| Report Source | 01 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-01-07 |
| Date Mfgr Received | 2013-07-31 |
| Date Added to Maude | 2013-09-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR ALEXANDER KRIEG |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MANNEDORF, ZURICH 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 | GENESIS FE 500 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2013-08-29 |
| Catalog Number | 10620300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ AG |
| Manufacturer Address | MANNEDORF, ZURICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-29 |