MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-16 for STA-R EVOLUTION IS (01)03607450589788(11)140312(21)4025362(241)589 manufactured by Diagnostica Stago.
[175237497]
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
[175237498]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043723-2020-00001 |
| MDR Report Key | 9595574 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-16 |
| 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 | MR BEN AMMAR |
| Manufacturer Street | 2 RUE PIERRE FOSSATI |
| Manufacturer City | FRANCONVILLE 95130 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95130 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | IS (01)03607450589788(11)140312(21)4025362(241)589 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |