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

Model Number	102208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/18/2025
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 high glucose event.The following example set was provided: date: (b)(6) 2025 - time: 4:38 pm where sg: 152 mg/dl - bg: 337 mg/dl.After dms review, we confirmed the following information at the time of the event: date: (b)(6) 2025 - time: 4:38 pm - sg: 152 mg/dl - bg: 337 mg/dl (confirmed via fingerstick).After dms review, we confirmed that the user didn't receive a high glucose alert at the time of the event because the sg never went above the alert level.The user didn't seek for medical treatment and resolved the event by being assisted by his wife with insulin.The user's hcp isn't aware of the event and was advised to follow up with the hcp for further medical guidance.
Additional Manufacturer Narrative
It was reported that the user experienced a hyperglycemic event.The following example was shared by the user.(b)(6) 2025 time: 4:38 pm cst - sg: 152 mg/dl - bg: 337 mg/dl.A review of the data management system (dms) data revealed that user's sg on (b)(6) 2025 at 5:38 pm est was 152 mg/dl and bg was 337 mg/dl.A review of the alert history revealed that the user did not receive any alerts during the reported time as their sg was below the set threshold.The user did not seek medical treatment and resolved the event by administering insulin themselves.User's hcp was not aware of the incident.The user was advised to follow up with the hcp for further medical guidance.A case (complaintrec-53969) was created to address sensor inaccuracies inclusive of the event and under this case it was determined that the sensor had deviated from normal behavior and an rma was issued for further investigation.Upon receipt of the rma, the sensor was tested, and a investigation on the sensor confirmed a loss of chemical performance due to hydrogel oxidation which could potentially result in sensor reading inaccuracies.B4.Date of this report 25 june 2025.G3.Date received by the manufacturer? 25 june 2025.H3.Device evaluated by manufacturer? yes.H6.Component code updated to 510.H6.Type of investigation updated to 10.H6.Investigation findings updated to 3231.H6.Investigation conclusions updated to 4307.

• 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: 21501309
• Report Number: 3009862700-2025-00275
• Device Sequence Number: 8020902
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 00817491022912
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/25/2025

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: 12/04/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 143125
• 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: 06/25/2025
• Initial Report FDA Received Date: 03/02/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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