MAUDE Adverse Event Report: SENSEONICS, INCORPORATED EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 102208-704

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.No data management system (dms) investigation was possible for this complaint since user did not provide exact date, time and glucose values of the incident.User did not provide any further information or if he had any symptoms.As a result, the complaint could not be confirmed.

Event Description

Senseonics was made aware of an incident where patient experienced a hyperglycemia event.User reported values above 330 mg/dl but did not specify any particular value.User also did not specify the exact date and time of the event.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18747481
• MDR Text Key: 335872960
• Report Number: 3009862700-2024-00253
• Device Sequence Number: 1
• Product Code: QCD
• 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: 02/21/2024

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: 10/02/2020
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 116211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2018
• 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): Other