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

Model Number	104208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05 april 2025,senseonics was made aware of an incident where user reported a high glucose event on 4-apr-2025 at 4:00 pm where user's sg was 80 mg/dl and bg was 547 mg/dl.After dms review, we confirmed that on (b)(6) 2025 at 4:00 pm where user's sg was 64 mg/dl and bg was not entered.After dms review, we confirmed that the user didn't receive a high glucose alert at the time of event because the sg never went above the alert level.The user didn't seek for medical treatment and didn't treat himself and waited for his glucose to go down naturally, as the authorized representative explained during the latest interaction that user was afraid of "crashing out" if user treated himself with insulin with his bg at that level.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 high glucose event on apr-04-2025 at 4:00 pm where user's sg was 80 mg/dl and bg was 547 mg/dl.A review of the data management system (dms) revealed that sg was 64 mg/dl and no bg was entered at the reported time.In an associated case for the user's complaint about sensor inaccuracy, a review of the sensor in vivo data showed transient optical instability, which was most likely due to the system stabilizing following insertion on 01 april 2025.The observed optical instability likely contributed to the sensor inaccuracy.A review of the sensor data from the two weeks following the event confirmed good agreement between sg and bg values, indicating that the system had stabilized and was performing within expected parameters.B4.Date of this report 04 july 2025.G3.Date received by the manufacturer? 04 july 2025.H3.Device evaluated by manufacturer?yes.H6.Component code updated to 510.H6.Type of investigation updated to 4121.H6.Investigation findings updated to 3224.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 21965239
• Report Number: 3009862700-2025-00545
• Device Sequence Number: 8112251
• 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): 07/04/2025

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: 12/04/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 02E365S
• 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: 04/05/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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
• Patient Age: 62 YR
• Patient Sex: Male