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

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

Patient Problems Abdominal Pain (1685); Gastritis (1874); Constipation (3274)

Event Date 01/24/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, senseonics was mae aware of an event where the user was admitted to the er for abdominal pain with symptoms of gastritis and constipation with a glucose value of 518 mg/dl.

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.Per case notes, the user who is a subject of the post approval study (pas) was admitted to the emergency room (er) for abdominal pain with symptoms of gastritis and constipation.User's glucose value was measured to be 518 mg/dl and was administered with insulin.Since, the user was not wearing the device at the time of the adverse event, the system wouldn't have triggered any alerts.No further investigation was found necessary for this complaint.

• 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: 14466315
• MDR Text Key: 292387151
• Report Number: 3009862700-2022-00091
• Device Sequence Number: 1
• Product Code: QHJ
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 20 YR
• Patient Sex: Male