MAUDE Adverse Event Report: Senseonics Inc. Eversense Sensor; Eversense Continuous Glucose Monitor System

Model Number	103606-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
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 there was some variability in the sg values.It was also observed that there were some periods of rapid glucose change and some calibrations being entered immediately following a period of no system use.As a proactive troubleshooting measure, customer care recommended a sensor-relink to clear the calibration history and correct any potential calibration misalignment.Post re-link additional monitoring showed that the bg values entered as calibrations during initialization phase fit sg trends well, with occasional differences due to lag between sg and bg inherent to the sensing technology and calibrations entered during periods of rapid glucose change.Customer care recommended the user continue using the system and to enter calibrations when glucose trends were not changing rapidly and to call back if they had any additional concerns.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.

• Brand Name: Eversense Sensor
• Common Device Name: Eversense Continuous Glucose Monitor System
• Manufacturer (Section D): Senseonics Inc.; 20451 seneca meadows parkway; germantown 20876 -700
• Manufacturer (Section G): Senseonics Inc.; 20451 seneca meadows parkway; germantown 20876 -700
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876--700
• MDR Report Key: 50927130
• Report Number: 3009862700-2026-03192
• Device Sequence Number: 18826230
• Product Code: SBA
• UDI-Device Identifier: 00817491024282
• UDI-Public: 00817491024282
• 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
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 103606-600
• Device Catalogue Number: FG-7500-00-301
• Device Lot Number: 01G152S
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• 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: 70 YR
• Patient Sex: Female