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

Device Problem Use of Device Problem (1670)

Patient Problem Hypoglycemia (1912)

Event Date 09/23/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.In eversense xl cgm system, the transmitter would always provide on-body vibration for all critical alerts.The user can always check the mobile medical application (mma) to review the alerts upon transmitter vibration.In eversense e3 cgm system, the mma has the capability to override the mobile device do not disturb (dnd) mode for low and out of range low glucose alerts.If the dnd override function is turned on by the user, the handheld mobile device would give out the audible alert for low and out of range low glucose alerts.In addition, the transmitter would always provide on-body vibration for all critical alerts.The user can always check the mma to review the alerts upon transmitter vibration.Therefore, eversense xl and e3 mma can always continue to provide a measurement and alert function in dnd mode.The asset details for the reported event was not provided, so the events could not be confirmed and no further investigation is possible at this time.A detailed explanation of how the glucose measurement app can continue to provide a measurement and alert function in the dnd mode was provided as part of response sent to bfarm on (b)(6) 2023.

Event Description

Senseonics was made aware of a hypoglycemia incident where user was not warned/alarmed by the system because the iphone had "driving mode" turned on (automatically) which blocked the alerts.

• 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: 18117209
• MDR Text Key: 327886106
• Report Number: 3009862700-2023-00241
• 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: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• 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: 01/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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