MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-19 for EVERSENSE SENSOR 102096-67A FG-4200-00-301 manufactured by Senseonics Inc..
[184264690]
This mdr is result of a retrospective review of complaints. User was provided with the escalation response, that the system is going through a period of instability and to allow a few more days for the system to stabilize. Initially user reported that the sensor accuracy was improving, but after a couple of days later, user called again alleging sensor inaccuracies and requesting sensor removal. User declined further troubleshooting. The sensor was removed from the user, without an rma. Further investigation is not possible as there is no material available to investigate.
Patient Sequence No: 1, Text Type: N, H10
[184264691]
On (b)(6) 2020,senseonics was made aware of a adverse event where user had a early sensor removal due to sensor inaccuracy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009862700-2020-00271 |
| MDR Report Key | 9857497 |
| Report Source | CONSUMER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-01-19 |
| Date of Event | 2020-01-19 |
| Date Mfgr Received | 2020-01-19 |
| Device Manufacturer Date | 2019-05-28 |
| Date Added to Maude | 2020-03-19 |
| 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 | MS. VALLIKANNU SOMASUNDARAM |
| Manufacturer Street | 20451 SENECA MEADOWS PARKWAY |
| Manufacturer City | GERMANTOWN, MD |
| Manufacturer Country | US |
| Manufacturer G1 | SENSEONICS INC. |
| Manufacturer Street | 20451 SENECA MEADOWS PARKWAY |
| Manufacturer City | GERMANTOWN,, MD |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVERSENSE SENSOR |
| Generic Name | EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Product Code | QCD |
| Date Received | 2020-03-19 |
| Model Number | 102096-67A |
| Catalog Number | FG-4200-00-301 |
| Lot Number | WP06515 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENSEONICS INC. |
| Manufacturer Address | 20451 SENECA MEADOWS PARKWAY GERMANTOWN,, MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |