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 Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sensonics was made aware of a serious adverse event where patient reported hypotension resulting in hospitalization.The incident was not related to eversense system.No additional information was provided by the clinic site.Since the event was not related to the usage of eversense cgm system, no additional evaluation was necessary.
Event or Problem Description
On 14 july 2025, sensonics was made aware of a serious adverse event where patient reported hypotension resulting in hospitalization.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• Manufacturer (Section D): SENSEONICS INC.; 20451 senenca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 senenca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 senenca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 22800957
• Report Number: 3009862700-2025-01160
• Device Sequence Number: 18407836
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 05/02/2025
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: 01E261S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Unknown