FDA Adverse Event
Malfunction
Summary report: N
EVERSENSE SENSOR
MDR report key: 23022930
·
Received September 10, 2025
Report
- Report Number
- 3009862700-2025-01474
- Event Type
- Malfunction
- Date Received
- September 10, 2025
- Date of Event
- August 10, 2025
- Report Date
- November 8, 2025
- Manufacturer
- SENSEONICS INC.
- Product Code
- SBA
- UDI-DI
- 00817491024282
- PMA / PMN Number
- P160048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE RMA WAS AUTHORIZED BUT NOT RECEIVED, THUS NO CONFIRMATION OR INVESTIGATION OF THE COMPLAINT WAS POSSIBLE. B4. DATE OF THIS REPORT 08 NOV 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 08 NOV 2025. H3. DEVICE EVALUATED BY MANUFACTURER? NO. H6. TYPE OF INVESTIGATION UPDATED TO 4114. H6. INVESTIGATION FINDINGS UPDATED TO 3221. H6. INVESTIGATION CONCLUSIONS UPDATED TO 67.
Additional Manufacturer Narrative · 0
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
ON 11 AUG 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2676600 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | SBA | SENSEONICS INC. | 103606-600 | 01E274S | 00817491024282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female |