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	Hypoglycemia (1912); Syncope/Fainting (4411)
Date of Event	08/30/2024
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 (b)(6) 2024 , senseonics was made aware of an event where the user reported passing out due to hypoglycemia with no alert asserted from the system.
Additional Manufacturer Narrative
The event reported on 31-aug-2024 at 9:33 pm, that the user passed out due to a low glucose event.The user didn't remember the sg or bg values at the time of event.A review of the data management system (dms) data was performed, and it was confirmed that on (b)(6) 2024 at 9:31 pm user's sg value was 146 mg/dl, and no bg value was entered.Dms review confirmed that the user didn't receive a low glucose alert at the time of the event because the sg was above the low alert level.However, the user received predicted low glucose alerts at 8:31 pm and 8:51 pm when the sg values were 75 mg/dl and 69 mg/dl respectively.The user didn't seek medical treatment and resolved the event by herself but didn't specify how.User's hcp was not aware of the event; the user was advised to follow up with the hcp for further medical guidance.In an associated case for the user's complaint of sensor inaccuracy, a review of the data management system (dms) revealed that the system went through a period of instability which recovered on (b)(6) 2024, 2 days after the event and there was good agreement between bg and sg values.The user is still using the system with no further complaints.The potential root cause for the reported sensor inaccuracy may be related to an issue with the sensor electronics, for example the led behavior at the time, or the in vivo state of the sensor hydrogel.B4.Date of this report 15 october 2024.G3.Date received by the manufacturer? 10 october 2024.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• 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: 20348415
• Report Number: 3009862700-2024-00966
• Device Sequence Number: 7842416
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 00817491022929
• 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): 10/15/2024

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: 08/14/2024
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 139541
• 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: 09/01/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female