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

Model Number	103606-610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Blister (4537); Skin Infection (4544)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Infection at the insertion site is a known and anticipated potential [tk4.1][mh4.2]adverse effect as described in the eversense user guide, which does not require additional investigation.A review of the device's manufacturing records indicated that the sensor lot met all requirements including sterilization requirements for release.
Event or Problem Description
On may 22, 2026, senseonics was made aware of a user's infection at the sensor insertion site.Symptoms included soreness, tenderness, and the formation of blisters that produced purulent discharge.The user attempted to manage the condition by puncturing the blisters with a sterilized needle and expressing the fluid; during this process, the sensor was unintentionally expelled from the arm.Data later showed reduced accuracy prior to the event and cessation of transmission consistent with the sensor's expulsion.Following the incident, symptoms were resolved without medical treatment, and the site healed with normal skin appearance.The user did not initially inform their healthcare provider but later followed up with their endocrinologist, who did not prescribe antibiotics and planned further evaluation.The user declined a replacement sensor and opted to continue using an alternative cgm system.

• Brand Name: EVERSENSE SENSO
• 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: 25537135
• Report Number: 3009862700-2026-02058
• Device Sequence Number: 15870705
• Product Code: SBA
• UDI-Device Identifier: 00817491024299
• UDI-Public: 817491024299
• 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): 06/17/2026

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: 103606-610
• 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: 05/22/2026
• Initial Report FDA Received Date: 06/17/2026
• 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: 74 YR
• Patient Sex: Female