MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 102096-67A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

Skin atrophy at insertion site is a known and anticipated potential adverse effect, which does not require additional investigation per (b)(4).Since user wanted the sensor to be removed from this arm, he was advised to contact the hcp for further guidance.No further resolution was found necessary for this complaint.

Event Description

On (b)(6) 2022, senseonics was made aware of an incident where the user experienced skin atrophy over the sensor which leads to sensor removal.

Manufacturer Narrative

Skin atrophy at insertion site is a known and anticipated potential adverse effect, which does not require additional investigation per (b)(4).Since user wanted the sensor to be removed from this arm, he was advised to contact the hcp for further guidance.No further resolution was found necessary for this complaint.

Event Description

On (b)(4) 2022, senseonics was made aware of an incident where the user experienced skin atrophy over the sensor which leads to sensor removal.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 13565424
• MDR Text Key: 285980811
• Report Number: 3009862700-2022-00035
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP05751
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male