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

Model Number 102208-704

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

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 12/27/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, senseonics was made aware of an instance where the user fainted in bathroom and had a seizure because of hypoglycemia.User's husband had to call ambulance.User was not taken to the hospital as she insisted to stay at home.Paramedics gave her glucose after which user felt better.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The complaint was investigated based on the available information.Data management system (dms) data revealed that the customer was provided various low glucose alerts beginning at 4:20 pm.It can be concluded that there is no indication of malfunction with system.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 19006858
• MDR Text Key: 338981368
• Report Number: 3009862700-2024-00121
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/26/2020
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 113503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2019
• 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