Model Number 101967-950 |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
Discomfort (2330)
|
Event Date 12/06/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The manufacturer is currently waiting for additional information regarding next sensor removal attempt.The additional information will be provided in the supplemental report.
|
|
Event Description
|
On december 27, 2023, senseonics was made aware of an incident where the previous sensor could not be removed during removal procedure on (b)(6) 2023.The next removal attempt will be done after (b)(6).
|
|
Manufacturer Narrative
|
The sensor was successfully removed and was inserted with a new sensor on (b)(6) 2024.Date of this report 10 june 2024 primary unique device identifier (udi) number updated to(b)(4).Explanted date updated to (b)(6) 2024.Date received by the manufacturer? 06 june 2024.
|
|
Search Alerts/Recalls
|