MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for EVERSENSE SENSOR 102096-67A FG-4200-00-301 manufactured by Senseonics Inc..
[183682195]
This mdr is result of a retrospective review of complaints. The complaint was confirmed by review of in-vivo data but the problem could not be duplicated during in-house investigation. The root cause was found to be unacceptably low value of reference on channel potentially due to insufficient hydration of hydrogel. The investigation shows the system correctly disabled the sensor due to performance failure and the system's self-test functions are working normally.
Patient Sequence No: 1, Text Type: N, H10
[183682196]
On (b)(6) 2019,senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009862700-2020-00266 |
| MDR Report Key | 9836767 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-16 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2019-11-25 |
| Device Manufacturer Date | 2019-05-11 |
| Date Added to Maude | 2020-03-16 |
| 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 | 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 | 2020-03-16 |
| Returned To Mfg | 2020-02-19 |
| Model Number | 102096-67A |
| Catalog Number | FG-4200-00-301 |
| Lot Number | WP06332 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-16 |