FDA Adverse Event
Injury
Summary report: N
EVERSENSE SENSOR
MDR report key: 22729489
·
Received August 6, 2025
Report
- Report Number
- 3009862700-2025-01077
- Event Type
- Injury
- Date Received
- August 6, 2025
- Date of Event
- July 6, 2025
- Report Date
- January 15, 2026
- Manufacturer
- SENSEONICS INC.
- Product Code
- QHJ
- PMA / PMN Number
- P160048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
D2B.CORRECTED FROM SBA TO QHJ.
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
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN UNSUCCESSFUL REMOVAL ATTEMPT OF THE SENSOR SN (B)(6) ON (B)(6) 2025. THE SENSOR'S SITE IS THE UPPER ARM. IT WAS CONFIRMED THAT AN INCISION WAS MADE TO ATTEMPT TO REMOVE THE SENSOR. SENSOR WAS PALPABLE BEFORE THE INCISION. TRANSMITTER WAS USED TO LOCALIZE THE SENSOR. ULTRASOUND AND MAGNET WASN'T USED TO LOCALIZE THE SENSOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133455 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS INC. | 101967-931 | WP09969 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |