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	Hypoglycemia (1912)
Date of Event	09/09/2024
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 september 10, 2024, senseonics was made aware of an incident where the user received a false hypoglycemia alert from the system due to sensor inaccuracy.The user reported on 9/9/24 around 7:00 pm that their sg was 49 mg/dl and bg was100 mg/dl.Per dms, the sg at 7:42pm was confirmed but the user's bg was not entered in the system.The user received a low glucose alert on (b)(6) 2024, at 7:42 pm.
Additional Manufacturer Narrative
The user reported receiving a low glucose alert on 09 sep 2024 around 7pm.The user mentioned that the sg at the time was 49 mg/dl while the bg was 100 mg/dl.A review of the dms data revealed that the sg value was 49 mg/dl at 7:42 pm and bg was not entered in the system.The user received low glucose alert at 7:27 pm and 7:42 pm.The user did not seek medical treatment or self-treat as the bg indicated that it was not in a hypoglycemia range.In an associated case of the user's complaint about sensor inaccuracy, it was determined that the system had experienced a period of instability on the date of the event, contributing to the differences observed.The transient instability may be potentially 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.The system has stabilized since and started displaying better agreement between the sensor readings and fingerstick measurements.The system has been performing within expectations.B4.Date of this report 23 october 2024.G3.Date received by the manufacturer? 14 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: 20425008
• Report Number: 3009862700-2024-00975
• Device Sequence Number: 20933238
• 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): 10/23/2024

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: 07/17/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 138758
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male