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

Model Number 102208-600

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

Patient Problem Stroke/CVA (1770)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

The user was hospitalized due to stroke and was monitored for 10 days.The incident was not related to eversense continuous glucose monitor system.No further investigation was found necessary as this was a non-device related incident.

Event Description

On january 17th, 2023, senseonics was made aware of a serious adverse event where the user had a stroke and was hospitalized from (b)(6) 2023 to (b)(6) 2023.This incident was not related to eversense continuous glucose monitor system.

• 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: 16382471
• MDR Text Key: 309615574
• Report Number: 3009862700-2023-00033
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/25/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 131449
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2022
• 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: 49 YR
• Patient Sex: Male