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

Model Number 102812-81A

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

Patient Problem Pain (1994)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Pain at insertion site is a known and anticipated potential adverse effect, which does not require additional investigation per (b)(4).Since user wanted to have the sensor removed, the user was advised to contact the inserting hcp to make an appointment for removal.She was also advised to contact the insurance directly to discuss about the coverage for the procedure.Further follow up regarding sensor removal was not possible due to lack of response from the user.

Event Description

On (b)(6) 2022,senseonics was made aware of an adverse event where user has a lot of pain on the surface of the arm where the sensor was inserted.User feels pain every time the transmitter is put on,taken off or even the surface is touched.User wanted to have the sensor removed, the user was advised to contact the inserting health care professional to make an appointment for removal.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 15645486
• MDR Text Key: 302166769
• Report Number: 3009862700-2022-00167
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 817491022974
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2023
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: 283370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2022
• 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 Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female