FDA Adverse Event
Malfunction
Summary report: N
EVERSENSE SENSOR
MDR report key: 24250544
·
Received February 3, 2026
Report
- Report Number
- 3009862700-2026-00148
- Event Type
- Malfunction
- Date Received
- February 3, 2026
- Date of Event
- January 3, 2026
- Report Date
- April 2, 2026
- Manufacturer
- SENSEONICS INC
- Product Code
- QHJ
- PMA / PMN Number
- P160048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 0
THE SENSOR WAS NOT RETURNED TO SENSEONICS BY THE TIME OF COMPLAIN CLOSURE. NO FURTHER INVESTIGATION WAS POSSIBLE WITHOUT THE PHYSICAL DEVICE RETURNED FOR EVALUATION TO CONFIRM ANY DEVICE MALFUNCTION.
Additional Manufacturer Narrative · 0
D2B.DEVICE PRODUCT CODE CORRECTED TO QHJ.
Description of Event or Problem · 0
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 |
|---|---|---|---|---|---|---|---|
| 313607 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QHJ | SENSEONICS INC | 101967-950 | 2001707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |