MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-14 for FREEDOM EVO 100 EVO-2 100 10641100 manufactured by Tecan Schweiz Ag.
[3592352]
The laboratory called to report carryover between samples resulting in (b)(6) samples. The evo 100 instrument is used to transfer samples from the tube to a 96 well plate. All other processing is performed offline. After a (b)(6) sample, subsequent samples pipetted with the same tip also come out (b)(6). The lab noted formation of bubbles on the ends of tips 2, 3, and 6 after aspiration, although they indicated they had not observed bubbles dropping off of tips. Carryover is observed across the microtiter plate, not just limited to tips 2, 3, and 6. Problem was reported as ongoing since installation of instrument in january 2012, although this was the first report to tecan. The laboratory performs (b)(6) for insurance company and does not report results to physicians. Results are reported to insurance companies and their clients. The laboratory reported that all (b)(6) samples are confirmed by a second method and confirmatory test by western blot. The laboratory could not rule out if any (b)(6) results had been obtained. The laboratory indicated they do not plan to investigate past test results.
Patient Sequence No: 1, Text Type: D, B5
[11011044]
A tecan field service engineer was dispatched to the laboratory to review the status of the instrument. The evoware log files were collected for review of the customer defined program for processing samples. The result of the review includes: the use of tween as part of the system fluid contributed to bubble formation - consider switching to di water without additives, include a decontamination step after each sample transfer, include an additional wash step at the beginning of the program, perform daily, weekly, monthly maintenance according to operator's manual and switch to using disposable tips from fixed tips. A gravimetric test was run on the instrument to verify dispense volumes. The gravimetric test did not meet manufacturer's specifications at the 10ul volume on tip. The dispense volume was around 15ul (too high). Fixed tip 6 was replaced and gravimetric tests rerun. All results met specification. The diagnostic test for fastwash and liquid detection test passed. It is likely that the use of fixed tips instead of disposable tips and insufficient use of decontamination and wash steps contributed to carryover. It is unclear if any false negative results occurred or if the failure in gravimetric test contributed to the carryover or potential for false negative results. Results are not used for treatment of patients and all positive samples are confirmed prior to reporting.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2013-00005 |
| MDR Report Key | 3303679 |
| Report Source | 05 |
| Date Received | 2013-08-14 |
| Date of Report | 2013-08-13 |
| Date of Event | 2013-07-19 |
| Date Mfgr Received | 2013-07-19 |
| Date Added to Maude | 2013-11-12 |
| 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 | 103 SEESTRASSE |
| Manufacturer City | MAENNEDORF, ZURICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 449228560 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO 100 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2013-08-14 |
| Model Number | EVO-2 100 |
| Catalog Number | 10641100 |
| 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 | MAENNEDORF, ZURICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-14 |