MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-10 for FREEDOM EVO 30020015 manufactured by Tecan Schweiz Ag.
[113880304]
Tecan received the logfiles from the customer. The analysis of the logfiles and information provided by the customer indicates that the device did not perform as intended. A malfunction was confirmed in sample tracking software v1. 1. While the software does generate reports for sample lds and will show the mismatch, the generation of the report is optional and must be selected by the user. The instructions in the application software manual for connecting clients indicate to use "connect all" which can provoke the bug generating loss of data and mismatches when multi-instrument mode is in use and one or more of the instruments is actively running. The software bug investigation has indicated that multiple error conditions must occur to provoke the bug: (1) multiple instruments are connected and running, (2) the communication to the sample tracking server is lost on one instrument (3) the user attempts to reconnect (4) a software warning message at the end of the run is not understood (5) the operator did not save the scan. Csv file (file with sample barcodes) and did not compare to the output report. If all of these conditions occur, then there is the possibility that the bug will occur with potential impact on sample identification/traceability. Based on this rare possibility, tecan is reporting the malfunction. In this specific event from the complaint, the lab detected the mismatch. There are no other known occurrences. 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
[113880305]
Tecan was informed on (b)(6) by the customer that their sample tracking software used on tecan freedom evo is not correctly capturing the sample data. They have an archive of the scan. Csv file in the script so they know it was scanned by the barcode reader. The sample id entries in the sample tracking reports do not match the scan. Csv files and the sample tracking report for one plate is missing the last 16 samples. The complaint did not lead to death or serious deterioration in the health of a patient or user. The laboratory confirmed the instrument is used for research use only and not for clinical diagnostic testing. Tecan is proactively investigating the occurence of this issue in similar systems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003402518-2018-00001 |
| MDR Report Key | 7673261 |
| Date Received | 2018-07-10 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-06-09 |
| Device Manufacturer Date | 2009-05-14 |
| Date Added to Maude | 2018-07-10 |
| 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. CLAUDIA SOLIMEO MENEGHISSE |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, ZH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer G1 | TECAN SCHWEIZ AG |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, ZH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8708 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3003402518-07/19/18-001C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREEDOM EVO |
| Generic Name | FREEDOM EVO 150 |
| Product Code | JQW |
| Date Received | 2018-07-10 |
| Model Number | 30020015 |
| 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, ZH 8708 SZ 8708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-10 |