FDA Adverse Event
Injury
Summary report: N
EVERSENSE SENSOR
MDR report key: 10623945
·
Received October 2, 2020
Report
- Report Number
- 3009862700-2020-00504
- Event Type
- Injury
- Date Received
- October 2, 2020
- Date of Event
- September 1, 2020
- Report Date
- September 2, 2020
- 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. D2: PRODUCT CODE CHANGED TO QHJ; H6: INVESTIGATION FINDINGS, UPDATED TO 3221; H6: INVESTIGATION CONCLUSIONS, UPDATED TO 4311.
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) 2020,SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR DESPITE OF TWO REMOVAL ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1085621 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QHJ | SENSEONICS INC. | 102096-67A | WP07477 | 00817491022349 |
| 1085622 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QHJ | SENSEONICS INC. | 102096-67A | WP07477 | 00817491022349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Male |