EVERSENSE SENSOR
Report
- Report Number
- 3009862700-2025-00649
- Event Type
- Injury
- Date Received
- May 24, 2025
- Date of Event
- September 12, 2022
- Report Date
- January 15, 2026
- Manufacturer
- SENSEONICS INC.
- Product Code
- QHJ
- UDI-DI
- 00817491022349
- PMA / PMN Number
- P160048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
INABILITY OR DIFFICULTY TO REMOVE SENSOR DURING FIRST ATTEMPT IS A KNOWN AND ANTICIPATED POTENTIAL RISK AND EVERSENSE USER GUIDE MENTIONS ABOUT IT UNDER "RISKS AND SIDE EFFECTS".USER STATED THAT HER HCP COULDN'T REMOVE THE SENSOR DURING THE LAST APPOINTMENT WHICH WAS IN (B)(6) 2022. THE USER CONTACTED CUSTOMER CARE TO SEEK ASSISTANCE IN FINDING AN HCP WHO CAN REMOVE THE SENSOR. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE USER TO PROVIDE ASSISTANCE. HOWEVER, NO RESPONSE WAS RECEIVED. THUS, NO FURTHER ACTIONS WERE POSSIBLE FOR THIS COMPLAINT. B4.DATE OF THIS REPORT 06 JUNE 2025. G3.DATE RECEIVED BY THE MANUFACTURER? 06 JUNE 2025. H6. INVESTIGATION FINDINGS UPDATED TO 4248. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4311.
D2B.CORRECTED FROM SBA TO QHJ.
ON 24 APRIL 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE HCP WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714503 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS INC. | 102096-67A | WP08507 | 00817491022349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Male |