MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR

Model Number	102096-81A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Senseonics was made aware of an incident where user reported an unsuccessful removal attempt of the sensor on (b)(6)2025.The sensor's site is the left arm.It was confirmed that an incision was made to attempt to remove the sensor.At the time of the call, the user was doing fine, but tired.Sensor was palpable before the incision.Transmitter and ultrasound weren't used to localize the sensor and only magnet was used to localize the sensor.However, the sensor was successfully removed during second removal attempt.As per dms, user is currently using the system with the new sensor and receiving up to date information.
Additional Manufacturer Narrative
Inability or difficulty to remove sensor during first attempt is a known and anticipated potential risk and eversense 365 user guide mentions about it under "risks and side effects".The user reported an unsuccessful removal attempt of the sensor on (b)(6)2025.The sensor's site is the left arm.It was confirmed that an incision was made to attempt to remove the sensor.At the time of the call, the user was doing fine, but tired.Sensor was palpable before the incision.Transmitter and ultrasound weren't used to localize the sensor and only magnet was used to localize the sensor.However, the sensor was successfully removed during second removal attempt.As per dms, user is currently using the system with the new sensor and receiving up to date information.This incident does not require any further investigation.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 22061638
• Report Number: 3009862700-2025-00576
• Device Sequence Number: 12671191
• Product Code: QHJ
• UDI-Device Identifier: 00817491022950
• UDI-Public: 00817491022950
• 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: 2025
• 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): 05/21/2025

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: 02/15/2025
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: 01E185S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male