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

Model Number 102208-610

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

Patient Problems Fatigue (1849); Muscle Weakness (1967); Anxiety (2328)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

The user was hospitalized due to a congenital adrenal hypoplasia precondition.He was informed at the hospital that he was low on cortisol and treated with steroids.It was advised that the user follow-up with his hcp for further medical guidance.Per case notes, the user is now doing fine.The reported event was not related to the eversense e3 cgm system.

Event Description

On july 18, 2023, senseonics was made aware of an adverse event where the user had to call the paramedics due to feeling really fatigued, tired, muscle weakness, and an anxious feeling after insertion on (b)(6) 2023.The user stated having a precondition called congenital adrenal hypoplasia and has to take steroid therapy which can sometimes cause symptoms like hypoglycemia.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 17499537
• MDR Text Key: 320792466
• Report Number: 3009862700-2023-00160
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2023
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 131252
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male