MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for EVOLUTION manufactured by Diagnostica Stago Gennevilliers.
[133716304]
On (b)(6) 2018, instrument reported incorrect pt results due to undetected bent needle. The vendor does not know why this happened. The pt received an unnecessary plasma transfusion and vitamin k.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083193 |
| MDR Report Key | 8256941 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-11-16 |
| Date Added to Maude | 2019-01-17 |
| 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 |
| 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 | EVOLUTION |
| Generic Name | SYSTEM, MULTIPURPOSE FOR INVITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2019-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO GENNEVILLIERS |
| Manufacturer Address | FIVE CENTURY DRIVE PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-16 |