MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-22 for THERMO SCIENTIFIC? TCAUTOMATION? TYPE 1020 952040 manufactured by Thermo Fisher Scientific Oy.
[133850809]
Based on the investigation results it was determined that after the tube for sample a was placed in the centrifuge module load rack, the operator stopped the centrifuge module but did not remove all the samples as required per the instructions in the user manual. The operator then started the centrifuge module by releasing the module lock but did not remove all the samples prior to releasing the module lock as required per the instructions in the user manual. The tcautomation software performed as designed by correctly identifying the sample identification (sid) mismatch by posting a cross check error message. The results of the investigation did not identify any failures with the system.
Patient Sequence No: 1, Text Type: N, H10
[133850810]
A customer reported that test results from a patient sample processed on the thermo scientific? Tcautomation? Laboratory automation system were mis-associated with the sample identification number (sid) of a different patient. Mis-associated patient results may lead to inappropriate physician action. The mis-associated patient test result was reported from the laboratory. There is no allegation of patient harm as a result of this event. The tcautomation software correctly identified the sid mismatch by posting a cross check failure message, as designed. This report corresponds to thermo fisher scientific (b)(4) complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610942-2019-00002 |
| MDR Report Key | 8266753 |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-25 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2017-01-20 |
| Date Added to Maude | 2019-01-22 |
| 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 | KATJA ERONEN |
| Manufacturer Street | RATASTIE 2 |
| Manufacturer City | VANTAA, 01620 |
| Manufacturer Country | FI |
| Manufacturer Postal | 01620 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMO SCIENTIFIC? TCAUTOMATION? |
| Generic Name | LABORATORY AUTOMATION SYSTEM |
| Product Code | LXG |
| Date Received | 2019-01-22 |
| Model Number | TYPE 1020 |
| Catalog Number | 952040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMO FISHER SCIENTIFIC OY |
| Manufacturer Address | RATASTIE 2 VANTAA, 01620 FI 01620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-22 |