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	05/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user reported discrepancies between bg and sg readings.Based on a review of the sensor data available in the data management system (dms), escalation analysis indicated that there was some variation in the sensor values, which could be attributable to the expected lag between bg and sg inherent to the sensing technology.As a proactive troubleshooting measure, customer care recommended a sensor-relink to allow the system to reinitialize and correct any potential calibration misalignment.Post re-link, additional monitoring showed that the system was working within expectations with bg values aligning well with sg trends.Customer care advised the user to continue using the system, entering any additional calibrations as prompted by the system.The user agreed with this assessment.As per the data management system (dms) review, the system remained in active use with up-to-date information.
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.

• 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: 25604317
• Report Number: 3009862700-2026-02184
• Device Sequence Number: 9914626
• 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: 2026
• 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): 06/23/2026

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 Model Number: 103606-610
• Device Catalogue Number: FG-7501-00-301
• Device Lot Number: 01G068S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2025
• 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: 67 YR
• Patient Sex: Male