MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for STA-R EVOLUTION 58978 manufactured by Diagnostica Stago.
[175246732]
There was poor vacuum at wash wells. The vacuum diaphragm was repaired. Investigations are still on going.
Patient Sequence No: 1, Text Type: N, H10
[175246733]
On (b)(6) 2019, the customer reported six erroneous ptt results had been produced and released. Qc results were within range before and after the erroneous results were produced. The customer later indicated (questionnaire dated (b)(6) 2019) that there were five patients involved, and stated that there were no life-threatening or permanent effects on the patients. At least one of the patients did receive heparin therapy based on the erroneous results. Corporate complaint file: (b)(4). Importer complaint file: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245451-2020-00001 |
| MDR Report Key | 9595990 |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-16 |
| Date Facility Aware | 2019-12-17 |
| Report Date | 2020-01-16 |
| Date Reported to FDA | 2020-01-16 |
| Date Reported to Mfgr | 2020-01-16 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA-R EVOLUTION |
| Generic Name | IVD COAGULATION DEVICE / INSTRUMENT |
| Product Code | JPA |
| Date Received | 2020-01-16 |
| Model Number | 58978 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO |
| Manufacturer Address | 3 ALL?E TH?R?SA ASNI?RES SUR SEINE, 92600 FR 92600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-16 |