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	Hyperglycemia (1905)
Date of Event	07/04/2025
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 patient attended visit 5.During the review of his diary, the study coordinator (sc) noted that on (b)(6) 2025, the patient reported a blood glucose level of 601 mg/dl, indicating a hyperglycemic episode.The patient stated that he went to the emergency room and was stabilized with insulin.The sc requested the hospital medical record for confirmation.The patient also reported that he did not use the transmitter at that time.He was discharged the same day and was not admitted to the hospital.
Additional Manufacturer Narrative
The patient reported experiencing a hyperglycemia event on (b)(6) 2025 with a blood glucose (bg) value of 601.The patient went to the emergency room (er) and was administered insulin.Per case notes, the patient was not using the transmitter at the time of event.Without transmitter, the system would not have triggered any "high" glucose alerts.The patient went back home the same day and no overnight hospitalization was required.No additional details were provided regarding the incident.B4.Date of this report 03 oct 2025.G3.Date received by the manufacturer? 03 oct 2025.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 4111.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 4310.

• 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: 23080912
• Report Number: 3009862700-2025-01426
• Device Sequence Number: 9738636
• 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: 2025
• 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): 10/03/2025

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: 06/28/2025
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09981
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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: 46 YR
• Patient Sex: Unknown