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

Model Number	102812-81A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Vomiting (2144); Dizziness (2194); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient expeirenced hyperglycemia and diabetic ketoacedosis on (b)(6) 2023 with symptoms of vomiting, dizziness and diarreha.The patient was admitted to hospital.The patient mentioned that her blood glucose (bg) monitor stopped notifying her of glucose value and threw an error message a day before, on (b)(6) 2023.It was not reported whether the patient was using eversense cgm at the time of incident or not.No further details were provided by the clinic site.Due to lack of information, no further investigation was possible for this complaint.
Event or Problem Description
Senseonics was made aware of a serious adverse event where the patient was hospitalized due to diabetic ketoacedosis on (b)(6) 2023.
Additional Manufacturer Narrative
B3.Date of event updated to (b)(6) 2023.B4.Date of this report updated to 04 november 2025.

• 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: 22075292
• Report Number: 3009862700-2025-00808
• Device Sequence Number: 13105038
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 00817491022974
• 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: 2023
• 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): 11/04/2025

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: 08/25/2023
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09029
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2022
• 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 Age: 52 YR
• Patient Sex: Unknown