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

Model Number	102208-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On 06 november 2024, senseonics was made aware of an incident where user reported a low glucose event on (b)(6) 2024 where sg was 119 mg/dl and bg was 58 mg/dl.After dms review on (b)(6) 2024 where sg was 119 mg/dl and bg was not available in dms.After dms review, we confirmed that the user didn't receive a low glucose alert at the time of event because the sg never went below the alert level.User didn't seek for medical treatment and resolved the event by eating some snacks.
Additional Manufacturer Narrative
On (b)(6) 2024, the user reported that the cgm system showed results that were different from glucometer measurements.Based on the escalation analysis, variability was observed, but the recovery period was slow.An option was given to the user to either wait while the system is stabilizing or to replace the sensor.The user opted to replace the sensor.The sensor was returned for further investigation, and upon receipt,a visual inspection showed a portion of hydrogel was observed to be damaged or missing from the back of the sensor.This missing hydrogel is most likely due to damage caused by excessive force applied by the removal clamps upon explant of the sensor and is unrelated to the user's complaint,and is not expected to impact functionality testing.A review of in vivo sensor data showed instable signal, reference channels from around dec 6th onwards.The instability is potentially due to poor recovery from impacts to the insertion site affecting the in vivo state of the hydrogel, such as the hydrogel interface being interfered with coagulated blood.Case notes do not mention any impact to the insertion site.However, we do not expect every minor to major impact to the insertion site to be memorable so confirmation from the user is not a requirement for concluding this type of behavior is potentially from an impact to the insertion site.This most likely contributed to the observed sensor inaccuracies.The rma was authorized to offer the user a sensor replacement.B4.Date of this report 15 april 2025 g3.Date received by the manufacturer? 15 april 2025 h6.Type of investigation updated to 10 h6.Investigation findings updated to 114 h6.Investigation conclusions updated to 4315.

• 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: 21076490
• Report Number: 3009862700-2025-00012
• Device Sequence Number: 6765478
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 00817491022929
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/15/2025

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: 07/06/2023
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 130606
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 01/05/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male