FDA Adverse Event
Injury
Summary report: N
EVERSENSE SENSOR
MDR report key: 11289671
·
Received February 5, 2021
Report
- Report Number
- 3009862700-2021-00019
- Event Type
- Injury
- Date Received
- February 5, 2021
- Date of Event
- January 7, 2021
- Report Date
- January 7, 2021
- 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
DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE USER THE REMOVAL STATUS OF THE SENSOR COULD NOT BE CONFIRMED. NO FURTHER INVESTIGATION WAS FOUND NECESSARY. D2. PRODUCT CODE UPDATED TO QHJ.
Additional Manufacturer Narrative · 1
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ON (B)(6) 2021, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184990 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QHJ | SENSEONICS INC. | 102096-67A | WP06190 | 00817491022349 |
| 184991 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QHJ | SENSEONICS INC. | 102096-67A | WP06190 | 00817491022349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Female |