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

Model Number	104208-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
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 of receiving low glucose alert on (b)(6) 2025 where bg was 100 mg/dl and sg was 46 mg/dl.After dms review,sg was 49 mg/dl at that time of event and no bg was taken.After dms review, we confirmed that the user received a low glucose alert at 08:00 am.The user didn't seek for medical treatment and didn't take any actions to solve the event because it was a false low event, and he had no symptoms.
Additional Manufacturer Narrative
The user reported a low glucose event on jan-08-2025 between 8:00 am cst where user's sg was 46 mg/dl and bg was 100 mg/dl.A review of the data management system (dms) data revealed that on 08-jan-2025 at 8:00 am cst user's sg was 45 mg/dl and bg was not entered.A review of the alert history revealed that the user received multiple low glucose alerts since 5:30 am as the user's sg value was below the threshold of 65 mg/dl.The user did not seek medical treatment and believed that they were not having a low glucose event.The user's hcp was aware of the event.An case (mfr#3009862700-2025-00195) was created to address the sensor inaccuracies related issues from the hypoglycemic event.A review of the in-vivo data revealed transient optical instability as the system adjusted from the implant process on the (b)(6) 2024.This most likely contributed to the sg/bg mismatch at the time of the low glucose event.A review of 2 weeks worth data post escalation (14 jan 2025 - 28 jan 2025) was analyzed, and the system had stabilized with good agreement between bg/sg.The user did not report any additional hypoglycemia/inaccuracies related issues and is currently using the same system b4.Date of this report 07 april 2025.G3.Date received by the manufacturer? 07 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: 21339145
• Report Number: 3009862700-2025-00111
• Device Sequence Number: 3759110
• Product Code: SBA
• UDI-Device Identifier: 00817491024244
• UDI-Public: 00817491024244
• 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): 04/07/2025

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: 09/13/2025
• Device Model Number: 104208-610
• Device Catalogue Number: FG-4001-01-001
• Device Lot Number: 01E316S
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• 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 Age: 59 YR
• Patient Sex: Female