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

Model Number	102096-81A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user reported going to the er due to pain and bleeding at the sensor site, which occurred on (b)(6) 2025; according to the user, the incision had reopened with blood discharge, and they felt as though the sensor was coming out of their arm on its own, prompting the er visit, although at the time of the call the user was feeling okay.The event was not related to sensor insertion or removal but was related to the eversense system.The user did not receive treatment at the hospital and was not prescribed any medication.The user's hcp is aware of the event, and the user was advised to continue following up with the hcp for further medical guidance.Per dms, the user has not been using the system since (b)(6) 2024 at 8:53 am due to the sensor reaching end of life.
Event or Problem Description
Senseonics was made aware of an incident where user reported going to the er due to pain and bleeding at the sensor site, which occurred on (b)(6) 2025; according to the user, the incision had reopened with blood discharge, and they felt as though the sensor was coming out of their arm on its own, prompting the er visit, although at the time of the call the user was feeling okay.The event was not related to sensor insertion or removal but was related to the eversense system.The user did not receive treatment at the hospital and was not prescribed any medication.The user's hcp was aware of the event, and the user was advised to continue following up with the hcp for further medical guidance.Per dms, the user has not been using the system since (b)(6) 2024 at 8:53 am due to the sensor reaching end of life.
Additional Manufacturer Narrative
D2b.Corrected from sba to qhj.

• 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: 23892611
• Report Number: 3009862700-2025-01980
• Device Sequence Number: 17281348
• 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: 2024
• 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): 01/15/2026

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 Expiration Date: 05/17/2024
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP09620
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown