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

Model Number	104208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
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 user reported receiving low glucose alerts on his system due to inaccuracy in sensor readings when the user's blood glucose was not low.After reviewing the user's information with the data available in dms, we confirmed only one instance where the user received a low glucose alert, on (b)(6) 2025 at 4:58 am when the sg was at 65 mg/dl.
Additional Manufacturer Narrative
On 17th jan 2025, the user reported that the system shows him low glucose alerts even when his blood glucose is not low.The user didn't provide any example sets related to low sg values that could trigger low glucose alerts.A review of the data management system (dms) data revealed that on (b)(6) 2025 that the user received multiple low glucose alerts from 4:58 am to 7:03 am (est) as user's sg value was below the threshold of 65 mg/dl.No bg values were entered the user.An s4 case (complaintrec-53415) was created to address the sensor inaccuracies related issues, inclusive of the low glucose event.A review of the in-vivo data revealed transient reference channel instability around dec 26th 2024 through jan 6th 2025.This potentially contributed to sg/bg mismatches the user may have observed at the time of the low glucose event.A review of 2 weeks worth data after the period of instability was analyzed (jan 6th to jan 20th), and the system had stabilized with good agreement between bg/sg and was working within expectations.The user did not provide any information on how the event was resolved.Per dms, the user is using the system with up to date information.B4.Date of this report 11 april 2025.G3.Date received by the manufacturer? 11 april 2025.H3.Device evaluated by manufacturer?yes.H6.Health effect - clinical code updated to 4582.H6.Type of investigation updated to 4121.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 21355674
• Report Number: 3009862700-2025-00103
• Device Sequence Number: 13001669
• Product Code: SBA
• UDI-Device Identifier: 00817491024237
• UDI-Public: 00817491024237
• 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): 04/11/2025

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: 10/10/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 01E326S
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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