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	Hypoglycemia (1912)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user reported hospitalization due to a hypoglycemic event on (b)(6) 2026.They stated they were stabilized before losing consciousness but required a toe amputation due to infection during their hospital stay.At the time of the call, the user reported feeling better.The event was diabetes-related, and the user provided the following example: (b)(6) 2026 at 1:16 pm est, sg 104 mg/dl and bg 38 mg/dl.Data management system review showed sg 104 mg/dl at that time with no bg entry.Alert history showed no low glucose alert at 1:16 pm.However, sensor data revealed prolonged hypoglycemia between 12:30 am and 1:11 pm on (b)(6) 2026, with 36 low glucose and 22 out-of-range low alerts during this time.Sg began rising at 1:16 pm, likely due to treatment (sugar and iv fluids).The user was prescribed iv fluids, and their hcp was aware of the event.Per case notes, the user reported prior doxycycline use.Tetracycline-class medications (e.G., doxycycline) may falsely lower cgm readings, and users are advised not to rely on cgm data while taking them, as indicated in the eversense user guide.The user was educated on this but stated they had not taken the medication for several weeks, including during hospitalization.A review of the in-vivo sensor data showed the system was performing within expectations, with no anomalies observed.Sg trends aligned with bg values, considering physiological lag that can occur between sg and bg.Occasional discrepancies were observed during rapid glucose changes, likely due to insulin, medication, or food intake.To address potential calibration misalignment, the user was advised to re-link the sensor as a proactive troubleshooting measure.This report was initially submitted on 08june2026, however it was submitted under an incorrect manufacturer fei number.It was originally submitted under 3009862000-2026-01864.
Event or Problem Description
On may 12, 2026, senseonics was made aware of a user's hypoglycemic event.The user reported a sensor glucose reading of 104 mg/dl and confirmed blood glucose of 38 mg/dl, which did not trigger alerts because the sensor value stayed above the low alert threshold.The user was hospitalized, treated with sugar, iv fluids, and antibiotics, and stabilized before losing consciousness.The user's healthcare provider was informed, and the user has since reported feeling better and continues to use the system with current data.

• 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 samasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 25681974
• Report Number: 3009862700-2026-01864
• Device Sequence Number: 21265241
• Product Code: SBA
• UDI-Device Identifier: 00817491024305
• UDI-Public: 817491024305
• 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): 07/01/2026

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 Model Number: 103606-620
• Device Catalogue Number: FG-7502-00-301
• Device Lot Number: 01G057S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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: 63 YR
• Patient Sex: Female