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

Model Number	102208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	01/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Senseonics was made aware of an incident where user experienced diabetic ketoacidosis between 7:30 pm and 8:30 pm on (b)(6) 2025.The user lost consciousness, became unresponsive, and was transported to a hospital by ambulance for emergency treatment.The user reported on (b)(6) 2025, between 7:30pm 8:30pm, sg was 178mg/dl and bg was 1000mg/dl.After dms review, on (b)(6) 2025, between 7:30pm 8:30pm sg did not go above 174mg/dl and no bg was entered at the time of the event.After dms review, we confirmed that the user didn't receive a low/high glucose alert at the time of event because the sg never went past the alert level.The user received insulin drips and potassium as treatment at the hospital.The user was prescribed insulin as medication.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
It was reported that the user had diabetic ketoacidosis on (b)(6) 2025 where the user lost consciousness, became unresponsive, and was hospitalized.He was transported to a hospital on an ambulance and treated by emergency service.The user reported on (b)(6) 2025, between 7:30pm to 8:30pm, where sg was 178 mg/dl and bg was 1000 mg/dl.A review of the data management system (dms) data revealed that (b)(6) 2025, between 7:30 pm to 8:30 pm where user's sg did not go above 174 mg/dl and no bg was entered at the time of the event.As a result, the reported event could not be confirmed.Per case information, the user received insulin drips and potassium as treatment at the hospital.The user was prescribed with insulin as medication.In an associated case for the user's complaint about sensor inaccuracy(complaintrec- (b)(4)),the blood glucose (bg) values entered into the system as calibrations fit sensor glucose (sg) trends well and the system was working within expectations.No further actions were possible for this complaint as the user stopped responding to the communications from customer care.B4.Date of this report 21 february 2025.G3.Date received by the manufacturer? 21 february 2025.H3.Device evaluated by manufacturer? yes.H6.Component code updated to 510.H6.Type of investigation updated to 4121.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 21340548
• Report Number: 3009862700-2025-00249
• Device Sequence Number: 14415286
• 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): 02/21/2025

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: 09/25/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 140620
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/08/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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: Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male