Model Number 102096-67A |
Device Problem
Failure to Sense (1559)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/31/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
|
|
Event Description
|
On (b)(6) 2020,senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.
|
|
Manufacturer Narrative
|
No rma was received and hence no investigation is possible.
|
|
Search Alerts/Recalls
|