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

Model Number	102208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/03/2024
Type of Reportable Event	Serious Injury
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 3, 2024, senseonics was made aware of an incident where the user experienced a hyperglycemia event with no alert from the system.
Additional Manufacturer Narrative
The user reported a hyperglycemic event on 03 august 2024 around 09:00 pm.The user mentioned that the sg at the time was 213 mg/dl while the bg was not taken.A review of the dms data revealed that the sg value was 213 mg/dl at 08:59 pm and no bg value was entered.The user didn't receive high glucose alerts at the reported time as the sg value was trending up but never went above the high alert threshold set by the user.A review of the alert history revealed that the user received a high glucose alert 10 minutes later at 9:09 am pt when the user's sg was 232 mg/dl.While investigating the event, the customer care team found that the user didn't notice the alert because he had the do not disturb mode enabled on his mobile device.The user did not seek medical treatment and resolved the event by taking insulin.The user's hcp was not made aware of the incident.The user was advised to follow up with the hcp for further medical guidance.A review of the system around the event date was performed, and the sg and bg values were in good agreement.The user is currently using the system with up-to-date data.B4.Date of this report 01 november 2024.G3.Date received by the manufacturer? 27 october 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 213.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 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: 20131162
• Report Number: 3009862700-2024-00902
• Device Sequence Number: 3226709
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 00817491022912
• 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): 11/01/2024

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: 09/18/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 140528
• 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: 08/03/2024
• Supplement Date Received by Manufacturer: 10/27/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male