MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number	103606-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Senseonics was made aware of an incident where user reported an event where the cgm showed results that are different from blood glucometer measurements.No injury or medical intervention was reported.
Additional Manufacturer Narrative
The user reported discrepancies between bg and sg readings.Review of the sensor data available in the data management system (dms), indicated that [tk8.1] the system was working within expectations and did not show any concerns about the health of the sensor.Overall, bg values meet the sg trends well.The observed differences were attributable to the expected lag between bg and sg inherent to the sensing technology.A firmware update was available at the time of the interaction; therefore, as a proactive troubleshooting measure, the user was advised to perform the update.System reinitialization occurs as part of the upgrade process, which clears the calibration buffer and addresses potential calibration misalignment.However, they declined reporting that they were seeing better accuracy in sensor readings.Per dms review, the user was using the system with up-to-date information.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• 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: 25513532
• Report Number: 3009862700-2026-02004
• Device Sequence Number: 21461621
• Product Code: SBA
• UDI-Device Identifier: 00817491024299
• UDI-Public: 00817491024299
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/28/2026
• Device Model Number: 103606-610
• Device Catalogue Number: FG-7501-00-301
• Device Lot Number: 02F227S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male