FDA Adverse Event
Malfunction
Summary report: N
EVERSENSE SENSOR
MDR report key: 12055652
·
Received June 23, 2021
Report
- Report Number
- 3009862700-2021-00085
- Event Type
- Malfunction
- Date Received
- June 23, 2021
- Date of Event
- May 21, 2021
- Report Date
- May 25, 2021
- Manufacturer
- SENSEONICS INC.
- Product Code
- QCD
- 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.
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 COMPLAINS OF HAVING LOW SIGNAL WITHIN THE TRANSMITTER AND SENSOR, LEADING TO EARLY SENSOR REMOVAL AS THE PATIENT WAS HAVING ISSUES WITH PLACEMENT GUIDE WEAK CONNECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 944432 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QCD | SENSEONICS INC. | 102096-67A | WP08273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |