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

Model Number 102208-995

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 02/08/2024

Event Type  Injury  

Event Description

On february 12, 2024, senseonics was made aware of an adverse event where the user reported a hypoglycemia event with no alert from the system due to sensor inaccuracy that left the user unconscious and led to hospitalization.

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Manufacturer Narrative

The investigation was performed on the user synced glucose data in data management system (dms), which is a cloud platform for eversense systems.Based on the review of the glucose data, the sensor glucose (sg) value on (b)(6) 2024 at 3:03 pm was 75 mg/dl and blood glucose (bg) value was not entered into the system.A low glucose alert was asserted at the time of event because sg value went below the alert threshold.The system performed as intended by asserting appropriate alerts.There was no system malfunction.The customer received medical treatment and is doing fine.A further review of the glucose plot indicated that sg readings matched calibrations closely during the two weeks following the reported event.The customer is currently using the system with up to date information.No further investigation was found necessary for this complaint.B4.Date of this report updated to 27 march 2024.G3.Date received by manufacturer updated to 27 march 2024.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• 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: 18900011
• MDR Text Key: 337618406
• Report Number: 3009862700-2024-00551
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2024
• Device Model Number: 102208-995
• Device Lot Number: 140942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization