EVERSENSE SENSOR
Report
- Report Number
- 3009862700-2025-01271
- Event Type
- Malfunction
- Date Received
- August 20, 2025
- Date of Event
- July 21, 2025
- Report Date
- January 15, 2026
- Manufacturer
- SENSEONICS INC.
- Product Code
- QHJ
- UDI-DI
- 00817491024282
- PMA / PMN Number
- P160048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
USER REPORTED AN EVENT WHERE HEAT AND SUNLIGHT CAUSED THE SENSOR GLUCOSE VALUES TO UP AND DOWN RAPIDLY. CASE WAS ESCALATED TO THE NEXT LEVEL OF SUPPORT. WHILE THE ISSUE WAS STILL BEING INVESTIGATED, USER WAS ADVISED TO MOVE TO A COOLER PLACE WHEN THE ISSUE OCCURS AND IF THE USER PLANS TO SPEND EXTENDED PERIODS OUTDOORS IN THE HEAT, WEARING A LIGHTWEIFGHT, LONG SLEEVED SHIRT CAN PROVIDE SOME PROTECTION. USER UNDERSTOOD THE INFORMATION AND ACKNOWLEDGED THE ISSUE IS STILL BEING INVESTIGATED. NO FURTHER ACTION WAS NEEDED AND AS PER DMS, USER WAS CURRENTLY USING THE SYSTEM WITH UP TO DATE INFORMATION.
D2B.CORRECTED FROM SBA TO QHJ.
B4. DATE OF THIS REPORT 14 SEPT 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 14 SEPT 2025. H6. INVESTIGATION FINDINGS UPDATED TO 104. H6. INVESTIGATION CONCLUSIONS UPDATED TO 58.
ON 21 JULY 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED SENSOR INACCURACY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1156068 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS INC. | 103606-600 | 02E264S | 00817491024282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female |