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	03/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On 01 april 2025, user reported a high glucose event.The following example set was provided: date: (b)(6) 2025, time: 6:10 pm est sg: 200 mg/dl bg: 387 mg/dl.After dms review, we confirmed the following information at the time of the event: date: (b)(6) 2025, time: 6:10 pm est sg: 200 mg/dl at 6:09pm est bg: 387 mg/dl (available in dms).After dms review, we confirmed that the user didn't receive a high glucose alert at the time of the event because the sg never went above the alert level.The user didn't seek for medical treatment and resolved the event by administering insulin.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 user reported receiving a high glucose event on mar-30-2025 at 6:10 pm where user's sg was 200 mg/dl and bg was 387 mg/dl.A review of the data management system (dms) data confirmed that on (b)(6)2025 at 9:29 pm user's sg was 200 mg/dl, and bg was 387 mg/dl.The alert history indicated that the user received did not receive a high glucose alert at the reported time as user's sg was below the user-defined threshold of 250 mg/dl.The user did not seek medical treatment and self-administered insulin to resolve the event.The user's hcp was not aware of the event and was advised the user to follow up with the hcp for further medical guidance.In an associated case for the user's complaint about sensor inaccuracy, a review of the raw sensor data showed transient optical instability, which is likely due to early wear adjustment of the system following insertion (b)(6) 2025.The user was advised to keep using the system and was educated on the expected behavior during the early wear period.A review of sensor data from the two weeks following the event confirmed good agreement between sg and bg values.B4.Date of this report 29 june 2025 g3.Date received by the manufacturer? 29 june 2025 h3.Device evaluated by manufacturer? yes 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 MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 21947086
• Report Number: 3009862700-2025-00552
• Device Sequence Number: 15662502
• 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): 06/29/2025

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: 10/10/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 01E326S
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 06/29/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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: 42 YR
• Patient Sex: Male