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

Model Number	102812-81A
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
Senseonics was made aware of an incident where user reported a low glucose event.The following example set was provided: (b)(6) 2025 (exact time not recalled by user).User estimated their bg at 15 mg/dl during the event.We are unable to confirm the details in dms because the user does not recall the exact time of the event or the sensor reading (sg) associated with the low glucose event.The user didn't seek for medical treatment and resolved the event by consuming food.The user's hcp isn't aware of the event, and user was advised to follow up with the hcp for further medical guidance.
Additional Manufacturer Narrative
The user reported a low glucose event on (b)(6)2025.The user estimated their bg at 15 mg/dl during the event.The reported event could not be confirmed as the user does not recall the exact time of the event or the sensor glucose (sg) associated with the low glucose event.A review of the alert history revealed that the sensor did not assert any low glucose alarms on the (b)(6) 2025 and the system was not in use between (b)(6) 2025 9:56 am and (b)(6) 2025 2:47 pm.The user did not seek medical treatment and resolve the event by consuming food.The user's hcp was not aware of the event and was advised to follow up with their hcp for medical guidance.The user confirmed that the system was not in use during the event.The customer care offered to assist the user with the app and sensor setup.The user is currently using the system with no further complaints on hypoglycemic events.B4.Date of this report 14 march 2025.D1.Brand name updated to eversense sensor.D2a.Common device name updated to implantable glucose monitoring system, sensor d4.Updated additional device information.G3.Date received by the manufacturer? 14 march 2025.H3.Device evaluated by manufacturer? yes.H4.Device manufacturing date updated to 11 december 2023.H6.Component code updated to 510.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• 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: 21501310
• Report Number: 3009862700-2025-00286
• Device Sequence Number: 12767651
• 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: 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): 03/14/2025

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 Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: 01E137S
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/02/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Unknown