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

Model Number	104208-600
Medical Device Problem Codes	Imprecision (1307); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Senseonics was made aware of an incident where the user reported going to the hospital due to a possible diabetic ketoacidosis (dka) event.According to the user, the elevated glucose levels may have been related to a bad pump site or possible food poisoning.The user stated that all supplies were changed, including fresh insulin, infusion site, and tubing.The user reported blood glucose levels above 250 mg/dl since approximately 1:30 am on (b)(6) 2025.Per laboratory results shared by the user, bg was 324 mg/dl, while the eversense system showed an sg of 255 mg/dl.The user later provided an update indicating that the event was not dka.The user reported that she was discharged and received fluids, and that sg and bg values were within 5 mg/dl of each other.
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 an emergency department visit that occurred on december 9, 2025, at approximately 1:30 am while using the system with a twist pump.The user stated that their blood glucose began running high (approximately 250 mg/dl or higher); they developed ketones up to 2.7, and experienced vomiting.The user also reported receiving a "no delivery" alarm after changing the infusion set and cartridge and did not perform a fingerstick measurement until arrival at the emergency department.In the emergency department, the user received iv fluids only and no additional insulin.The user did not meet the criteria for diabetic ketoacidosis and was discharged home.The following example was provided by the user on (b)(6) 2025, bg 324 mg/dl and sg 255 mg/dl.Review of the data management system (dms) confirmed that on (b)(6) 2025, at 6:58 am the user's sg was 250 mg/dl, and at 7:00 am the user entered a bg of 324 mg/dl.A review of alert history showed the user received high glucose alerts approximately every 30 minutes between 2:13 am and 9:55 am, and review of glucose data showed sg trending upward between approximately 1:18 am and 2:53 am.In an associated case of sensor inaccuracy, a review of in vivo data indicated that most observed differences were potentially due to inherent lag in the sensing technology of the sensor.Review of in vivo raw sensor data did not identify anomalies that would impact accuracy around the reported timeframe.The user later spoke with senseonics' chief medical officer and acknowledged that the observed differences were consistent with lag, and that overall system performance was within expectations.B4.Date of this report 23 jan 2026.D1 and d2a suspect medical device updated.D4.Additional device information updated.G3.Date received by the manufacturer? 23 jan 2026.H3.Device evaluated by manufacturer?yes.H6.Health effect - clinical code updated to 1905.H6.Health effect -impact code updated to 4614.H6.Medical device problem code updated to 1307.H6.Component code updated to 3141.H6.Type of investigation updated to 4121.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 22.

• 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: 24016836
• Report Number: 3009862700-2026-00050
• Device Sequence Number: 18787594
• 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
• Device Implanted Year: 2025
• 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): 01/23/2026

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: 08/01/2026
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 01F239S
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown