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

Model Number	102208-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hyperglycemia (1905); Convulsion/Seizure (4406)
Date of Event	01/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, senseonics was made aware of an adverse event where user reported "a severe insulin reaction resulting in seizure" and "crashing.".
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
User's initial complaint was received on (b)(6) 2022 about sensor inaccuracies, but no specific examples or dates were provided.User also mentioned that she still had bruising at the insertion site, and customer care recommended to have the bruising examined by hcp as the bruising could have potentially affected the temporary sensor inaccuracies reported by the user.Customer care made several attempts to follow up with the user, however no response was received from the user.User also complained about not receiving predictive alerts, but this was due to the functionality being disabled in the system by the user.On (b)(6) 2023, a social media comment was posted by the user where she reported the serious adverse event, however, no date of event was provided by the user.Customer care again made several attempts to follow up with the user, however, the user remained unresponsive.Based on the review of sensor data synced by the user in dms, the overall system performance was within expectations, with some occasional lag that's inherent to the system.Since no specific examples of sensor inaccuracies or the date for the adverse event were provided, no further investigation was possible.Customer case made several attempts to follow up with the user, however, the user remained unresponsive.The system was in use until (b)(6) 2022 per dms.User had mentioned a wish to have the sensor removed, however, the removal status could not be confirmed due to no response from the user.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 16274822
• Report Number: 3009862700-2023-00025
• Device Sequence Number: 20341833
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• 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): 01/02/2023

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: 05/18/2023
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 129743
• 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: 01/02/2023
• Supplement Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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: 50 YR
• Patient Sex: Female