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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01 may 2025, senseonics was made aware of an incident where user reported an event where the cgm showed results that are different from glucometer measurements.No injury or medical intervention was reported.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
On (b)(6) 2025, the user reported that the system showed results that differed from glucometer measurements.The case was escalated to the next level of support for further review.An initial review of data management system (dms), the cloud platform for eversense system, revealed patterns consistent with situations in which estimated values were entered as calibrations instead of actual bg meter values.The user was advised that only true bg meter values, obtained via fingerstick, should be used for calibration.Entering estimated values or readings from the eversense cgm or another cgm, can disrupt the calibration process and lead to significant deviations in the sensor readings.In addition to improper calibration entries, it was noted that the user was using outdated transmitter firmware, which may have contributed to the observed sensor inaccuracies due to suboptimal communication with the sensor.As the user did not have access to a computer to update the firmware, a replacement transmitter with the latest firmware was provided.The updated firmware included enhanced antenna calibration to improve communication with the sensor.The returned transmitter was tested in-house, and no malfunction was identified based on the investigation findings.The user resumed use of the system with the new transmitter, and a review of sensor data from the two weeks following the event confirmed good agreement between sg and bg values.B4.Date of this report 29 july 2025.G3.Date received by the manufacturer? 29 july 2025.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 4121.H6.Investigation findings updated to 628,4248.H6.Investigation conclusions updated to 58,19.

• 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: 22553720
• Report Number: 3009862700-2025-01155
• Device Sequence Number: 9559914
• 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
• 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): 07/29/2025

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: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 02E284S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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
• Patient Age: 66 YR
• Patient Sex: Female