FDA Adverse Event
Malfunction
Summary report: N
EVERSENSE SENSOR
MDR report key: 11815309
·
Received May 12, 2021
Report
- Report Number
- 3009862700-2021-00074
- Event Type
- Malfunction
- Date Received
- May 12, 2021
- Date of Event
- April 16, 2021
- Report Date
- April 16, 2021
- Manufacturer
- SENSEONICS INC.
- Product Code
- QCD
- UDI-DI
- 00817491022349
- PMA / PMN Number
- P160048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE RMA WAS AUTHORIZED BUT NOT RECEIVED SO NO FURTHER CONFIRMATION OR INVESTIGATION OF THE COMPLAINT IS POSSIBLE. AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED TO OFFER THE USER A SENSOR REPLACEMENT. H3. DEVICE EVALUATED BY MANUFACTURER? NO, NOT RETURNED TO MANUFACTURER. H6. TYPE OF INVESTIGATION UPDATED TO 4114. H6. INVESTIGATION FINDINGS UPDATED TO 3221. H6. INVESTIGATION CONCLUSIONS UPDATED TO 67.
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 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 |
|---|---|---|---|---|---|---|---|
| 708445 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QCD | SENSEONICS INC. | 102096-67A | WP08239 | 00817491022349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |