FDA Adverse Event
Injury
Summary report: N
EVERSENSE SENSOR
MDR report key: 14146656
·
Received April 19, 2022
Report
- Report Number
- 3009862700-2022-00060
- Event Type
- Injury
- Date Received
- April 19, 2022
- Date of Event
- March 18, 2022
- Report Date
- March 18, 2022
- 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
Additional Manufacturer Narrative · 0
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 0
DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE USER, THE STATUS OF THE BROKEN SENSOR COULD NOT BE CONFIRMED. SINCE THE USER WAS NOT RESPONSIVE THE COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 0
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USERS SENSOR BROKE DURING THE REMOVAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2716519 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QHJ | SENSEONICS INC. | 102096-67A | WP07588 | 00817491022349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female |