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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer provided an explanation of the issue to the user.No further investigation was found necessary for this complaint.
Event or Problem Description
On (b)(6) 2025, senseonics was made aware of an incident where user experienced sensor inaccuracy.The customer was educated on the lag between cgm and bgm readings and advised enter any additional calibrations requested by the system.No injury or medical intervention was reported.
Additional Manufacturer Narrative
The customer contacted customer care reporting inaccurate glucose readings.The customer had been calibrating correctly and was not undergoing any medical treatments that could affect the readings.However, significant discrepancies were noted between sensor glucose (sg) and blood glucose (bg) values, such as sg 100 mm/dl and bg 184 mm/dl.The customer was educated about potential causes for these differences, including the lag between bg and interstitial fluid readings.The issue seemed resolved after this explanation, and the customer was advised to perform an additional calibration mid-week to improve accuracy.Later that day, the customer reported continued misreadings, particularly at night, and requested a deeper review of the case.On (b)(6), the next level support staff reviewed the system and found no indication of an issue, attributing the differences to lag and calibrations during rapid glucose changes.The customer was advised to continue using the system and calibrate when glucose levels were stable.B4.Date of this report 28 april 2025.D1 and d2 updated.D4.Updated additional device information.G3.Date received by the manufacturer? 11 april 2025.H3.Device evaluated by manufacturer? yes.H4.Device manufacturing date updated to 12 august 2024.H6.Component code updated to 3141.H6.Type of investigation updated to 4112.

• 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: 21381824
• Report Number: 3009862700-2025-00144
• Device Sequence Number: 8471529
• 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
• Device Implanted Year: 2024
• 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): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/11/2025
• Device Model Number: 104208-610
• Device Catalogue Number: FG-4001-01-001
• Device Lot Number: 01E285S
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Male