MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number	104208-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently performing investigation and results will be provided in a supplemental report.
Event or Problem Description
On 27 december 2024,senseonics was made aware of an incident where user reported a low glucose event on 22 december 2024 where sg was 45 mg/dl and bg was 135 mg/dl.After dms review on 27 december 2024 where sg was 67 mg/dl and bg was 135 mg/dl.After dms review, we confirmed that the user received a low glucose alert at 9:15 am as glucose was going down, when the sg was at 61mg/dl.The user didn't seek for medical treatment and didn't take any actions to solve the event because he confirmed that it was a false low event, and he had no symptoms.
Additional Manufacturer Narrative
The user reported receiving low glucose alert on (b)(6) 2024 at 9:00 am, where sg was 45 mg/dl and bg 135 was mg/dl.A review of the data management system (dms) data revealed that on (b)(6) 2024 at 9:00 am user's sg was 114 mg/dl and bg was 135 mg/dl.However, user's sg was trending down, and the user received a log glucose alert at 10:15 am when the sg was 61 mg/dl.A review of the alert history revealed that the user received multiple low glucose alerts since 10:15 am as 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 not aware of the event.The user was advised to follow up with their hcp for medical guidance.In an associated case for the user's complaint about sensor inaccuracy (b)(4), a review of the in-vivo data revealed optical instability around (b)(6)2024.The user also reported an infection (mfr# 3009862700-2025-00057) at the insertion site which most likely contributed to the optical instability and consequent sg/bg mismatch at the time of the event.B4.Date of this report 07 february 2025.D4.Updated additional device information.G3.Date received by the manufacturer? 07 february 2025.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 4121.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 44.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• 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: 21238073
• Report Number: 3009862700-2025-00048
• Device Sequence Number: 18406892
• 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): 02/07/2025

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: 12/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male