MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR

Model Number	104208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Senseonics was made aware of an incident where user reported a low glucose event on (b)(6) 2025 at 01:24 am,bg was 67 mg/dl and sg was 53 mg/dl.After dms review, we confirmed that the user received a low glucose alert at 1:12 am mt, when the sg was at 60 mg/dl.The user didn't have a low glucose event so he didn't treat himself, but he mentioned that he eats small amounts of carbs before sleeping to keep his bg above levels.The user's hcp isn't aware of the event and was advised to follow up with the hcp for further medical guidance.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
The user reported a low glucose event on (b)(6) 2025 1:24 am mt where user's sg was 53 mg/dl abd bg was 67 mg/dl.A review of the data management system (dms) data revealed that on (b)(6) 2025 at 1:22 am mst user's sg was 53 mg/dl and bg was 67 mg/dl.A review of the alert history revealed that the user received multiple low glucose alert since 12:17 am as user's sg value was below the threshold of 65 mg/dluser did not seek medical treatment and believed that they were not having a low glucose event.But mentioned that he eats small amounts of carbs before sleeping to keep his bg above levels.User's hcp was not aware of the event.The user was advised to follow up with their hcp for medical guidance.An case (b)(4) was created to address the sensor's inaccuracies at the time of the event and under this case it was determined that the sensor had deviated from normal behavior and an rma was issued for further investigation.Sensor and transmitter were returned from the field.Upon receipt, visual inspection and functional testing was performed and no anomalies were observed for all returned parts.The failure mode could not be reproduced during the returned product analysis testing, and this may occur in some instances where the failure mode that presents itself in the body is not reproduced in the lab.The potential root of inaccuracies cause may be related to an issue with the in vivo state of the sensor hydrogel.B4: date of this report (b)(6) 2025.G3.Date received by the manufacturer? 12 may 2025.H3.Device evaluated by manufacturer? yes h6.Health effect - clinical code updated to 4582.H6.Component code updated to 510.H6.Type of investigation updated to 10.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 21417802
• Report Number: 3009862700-2025-00096
• Device Sequence Number: 15349946
• Product Code: SBA
• UDI-Device Identifier: 00817491024237
• UDI-Public: 00817491024237
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/11/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 02E284S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male