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

Model Number 102208-807

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 09/28/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.There was no material available to investigate, and no response was received when more information was requested from the user.Per the user's response as of (b)(6) 2019, the user was doing fine and had no complaints with the system.Dms confirmed that the system was operating normally.

Event Description

On october 8, 2019, senseonics became aware of an event where a user was hospitalized due to a hypoglycemia event with no alert from the eversense 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: 18418969
• MDR Text Key: 331606347
• Report Number: 3009862700-2023-00410
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 12/29/2023

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: 03/27/2020
• Device Model Number: 102208-807
• Device Catalogue Number: FG-3400-07-101
• Device Lot Number: 112870
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2019
• 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