MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; Sensor, glucose, implanted, non-adjunctive use

Catalog Number	FG-7201-00-301
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	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User reported bleeding and pain at the sensor removal site.According to the user, the removal was difficult and performed while she was sitting, resulting in a larger-than-usual horizontal incision.Hours after the procedure, she noticed active bleeding, and the bandage was fully soaked in blood.She removed the blood-soaked bandage herself, causing the steri-strips to come off prematurely.The event was related to the sensor removal.The event was not related to diabetes, so no glucose data was required or provided.User visited an emergency room but was not treated due to insurance restrictions.No medication was prescribed.She planned to follow up at an insurance-covered clinic the following day.Bleeding and pain at the insertion site are known and anticipated potential adverse effects associated with sensor insertion / removal, which do not require additional investigation.
Event or Problem Description
Senseonics was made aware of an adverse event where the customer went to emergency room because of bleeding and pain at the insertion site after sensor removal was performed.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: Sensor, glucose, implanted, non-adjunctive use
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 22408144
• Report Number: 3009862700-2025-00907
• Device Sequence Number: 8304219
• Product Code: QHJ
• UDI-Device Identifier: 00817491022967
• UDI-Public: 00817491022967
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2025

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: 12/06/2024
• Device Catalogue Number: FG-7201-00-301
• Device Lot Number: 01E145S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2025
• 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