FDA Adverse Event
Malfunction
Summary report: N
EVERSENSE SENSOR
MDR report key: 12931677
·
Received December 5, 2021
Report
- Report Number
- 3009862700-2021-00146
- Event Type
- Malfunction
- Date Received
- December 5, 2021
- Date of Event
- October 28, 2021
- Report Date
- November 5, 2021
- Manufacturer
- SENSEONICS INC.
- Product Code
- QCD
- PMA / PMN Number
- P160048
- Product Problem
- 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
THE RMA WAS AUTHORIZED BUT NOT RECEIVED, THUS NO CONFIRMATION OR INVESTIGATION OF THE COMPLAINT WAS 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.
Description of Event or Problem · 0
ON 05TH NOVEMEBER 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 |
|---|---|---|---|---|---|---|---|
| 1829369 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QCD | SENSEONICS INC. | 102096-67A | WP08435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female |