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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 09/07/2023

Event Type  Injury  

Event Description

On september 8, 2023, senseonics was made aware of an incident where the user experienced symptoms of hypoglycemia while receiving a high glucose alert from the system due to sensor inaccuracy.

Manufacturer Narrative

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

Manufacturer Narrative

The user reported feeling symptoms of hypoglycemia on (b)(6) 2023, while receiving a high glucose alert from the system.The user did not confirm with his bg meter, but self-treated by eating a mango and did not seek any medical treatment.The event happened a few days after the insertion when the system was in the early wear period, and the observed variations may be due to the sensor still stabilizing after insertion.In an associated complaint of sensor inaccuracy, the sensor in-vivo data was reviewed, which did not indicate any performance malfunction.Sensor readings closely matched calibrations two weeks following the early wear adjustment period, and the current system performance is within expectations.The user is using the system with up-to-date information.No further resolution was found necessary for this complaint.B4.Date of this report updated to (b)(6) 2023.G3.Date received by manufacturer updated to 20 october 2023.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 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: 17891062
• MDR Text Key: 325231422
• Report Number: 3009862700-2023-00198
• 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,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/26/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 132235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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): Other
• Patient Age: 70 YR
• Patient Sex: Male