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

Model Number	103606-620
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2026
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.Escalation analysis indicated that the system was experiencing a period of transient optical instability.Customer care recommended that the user re-link their sensor to allow the system to reinitialize and converge faster.Post re-link, additional monitoring showed that there were situations in which estimated values provided by the evesense app were entered as calibrations rather than true bg values.Customer care intened to advise the user to enter only blood glucose meter values obtained via fingerstick when calibrating, as use of estimated values or other sources may affect system performance.However, further follow-up with the user was not possible as the user remained unresponsive to multiple communication attempts, and this guidance could not be communicated.As per the data management system (dms) review, the system remained in active use 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 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 25661015
• Report Number: 3009862700-2026-02092
• Device Sequence Number: 10447493
• Product Code: SBA
• UDI-Device Identifier: 00817491024305
• UDI-Public: 00817491024305
• 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): 06/29/2026

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: 103606-620
• Device Catalogue Number: FG-7502-00-301
• Device Lot Number: 03F227S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2026
• Initial Report FDA Received Date: 06/29/2026
• 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: 66 YR
• Patient Sex: Female