MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for STAGO EVOLUTION manufactured by Diagnostica Stago, Inc..
[133939985]
On (b)(6) 2018, instrument reported incorrect patient results due to an undetected bent needle. The vendor does not know why this happened. The patient received an unnecessary plasma transfusion and vitamin k. Original inr reported as 2. 52 ((b)(6) 2018 at 04:58 am). Corrected inr reported as 1. 22 ((b)(6) 2018 at 12:58pm). Original fibrinogen reported as 198 mg/dl ((b)(6) 2018 at 04:58 am). Corrected fibrinogen reported as 397 mg/dl ((b)(6) 2018 at 12:58 pm). Original heparin xa reported as <0. 10 iu/ml ((b)(6) 2018 at 04:58 am). Corrected heparin xa reported as 0. 14 iu/ml ((b)(6) 2018 at 12:58 pm). Original d-dimer reported as 9. 7 ug/ml ((b)(6) 2018 at 04:58 am). Corrected d-dimer reported as 17. 5 ug/ml ((b)(6) 2018 at 12:58 pm).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083226 |
| MDR Report Key | 8260917 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-11-16 |
| Date Added to Maude | 2019-01-18 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | STAGO EVOLUTION |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2019-01-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO, INC. |
| Manufacturer Address | FIVE CENTURY DR. PARISIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-17 |