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	Hypoglycemia (1912)
Date of Event	01/09/2025
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
Senseonics was made aware of an incident where user reported a low glucose event on (b)(6) 2025 between 02:00 am to 04:00 pm where user's sg was 57 mg/dl and bg was 120 mg/dl.Since user couldn't provide a specific date of event, the following information was confirmed in dms using the information value provided, where sg was 57 mg/dl confirmed on (b)(6)2025 at 2:35 am and bg 120 mg/dl wasn't entered into the system.The user received the first low glucose alert at 2:10 am, when the sg was at 58 mg/dl, and kept receiving alerts every 15 minutes.The user didn't seek for medical treatment and resolved the event because he had no symptoms of a low glucose event.The user was advised to follow up with the hcp for further medical guidance.
Additional Manufacturer Narrative
The user reported a low glucose event on (b)(6) 2025 between 2:00 am - 4:00 am where user's sg was 57 mg/dl and bg was 120 mg/dl.A review of the data management system (dms) data revealed that on (b)(6) 2025 at 2:35 am user's sg was 57 mg/dl and bg was not entered.A review of the alert history revealed that the user received multiple low glucose alerts since 2:10 am as user's sg value was below the threshold of 60 mg/dl.The user did not seek medical treatment and believed that they were not having a low glucose event.The user's hcp was not aware of the event and was advised to follow up with their hcp for medical guidance.An case (b)(4) was created to address the sensor inaccuracies related issues, inclusive of the hypoglycemia event.A review of the in-vivo data revealed transient optical instability as the system adjusted from implant on the (b)(6) 2024.This most likely contributed to the sg/bg mismatch at the time of the low glucose event.A review of 2 weeks' worth data post escalation ((b)(6) 2025) was analyzed, and the system had stabilized with good agreement between bg/sg.The user did not report any additional hypoglycemia/inaccuracies related issues and is currently using the same system, by closure of this complaint.B4.Date of this report (b)(6) 2025.G3.Date received by the manufacturer? 08 april 2025.H3.Device evaluated by manufacturer?yes.H6.Health effect -impact code updated to 4613.H6.Component code updated to 510.H6.Investigation findings updated to 114.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: 21340543
• Report Number: 3009862700-2025-00201
• Device Sequence Number: 3849120
• 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): 04/08/2025

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: 01/09/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/08/2025
• Supplement Report FDA Received Date: 04/08/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male