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

Model Number	102620-81A
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On august 7, 2024, senseonics was made aware of an incident where the user experienced sensor inaccuracy which led to early sensor removal.
Additional Manufacturer Narrative
The sensor replacement alert was first presented to the user on (b)(6) 2024, day 136 after insertion.The sensor was tested in-house, and the review of investigation analysis revealed a loss of chemical performance.The system correctly disabled the sensor when it detected the performance failure, and the system's self-test functions were working normally.The root cause of the performance failure was due to the sensor's hydrogel oxidation.As part of resolution, a return material authorization was issued for sensor replacement.No further resolution was necessary for this complaint.B4.Date of this report (b)(6) 2024.D9 device available for evaluation? yes, device received on 09/24/2024.G3 date received by the manufacturer? 08 october 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 3231.H6.Investigation conclusions updated to 4307.

• Brand Name: EVERSENSE SENSOR
• 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: 20163409
• Report Number: 3009862700-2024-00912
• Device Sequence Number: 7291320
• Product Code: QHJ
• UDI-Device Identifier: 00817491022967
• UDI-Public: 00817491022967
• 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): 11/04/2024

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: 08/10/2024
• Device Model Number: 102620-81A
• Device Catalogue Number: FG-7201-00-301
• Device Lot Number: WP09730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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: 52 YR
• Patient Sex: Female