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	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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 (b)(6) 2024, around 11:00 pm that their sg was 55 mg/dl and bg was 127 mg/dl.Per dms, the sg and bg values were confirmed and user received a low glucose alert on (b)(6) 2024, at 11:36 pm.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
The user reported a low glucose event on 25sep 2024 around 11:42pm.The user mentioned that the sg at the time was 55 mg/dl while the bg was 127 mg/dl.A review of the dms data revealed that the sg value was 52 mg/dl at 11:41 pm and bg was 127 mg/dl 11:42 pm.A review of the alert history revealed that the user received multiple low glucose alerts since 11:21 pm.The user did not seek medical treatment and resolved the event by eating something.User's hcp was not aware of the event.The user was advised to get in touch with their hcp for any medical assistance.A case (complaint: (b)(4) was created to address the sensor inaccuracies.An initial review of the system revealed that the signal and reference channels were trending up and were trying to get stabilized.The user was inserted on (b)(6) 2024.It is expected to see some differences during the early days as the system tries to get stabilized.The system was monitored for a few days and the user was educated about the expected inaccuracies during early days.The sensor is currently in use and the system is displaying good agreement between the sensor readings and calibration entries between on (b)(6) 2024.The most likely root cause of the reported inaccuracies can be attributed to early wear adjustment.No further investigation is required.B4.Date of this report updated to 08 november 2024.G3 date received by the manufacturer? 04 november 2024.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: 20529732
• Report Number: 3009862700-2024-00999
• Device Sequence Number: 9105676
• 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): 11/08/2024

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: 08/21/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 139702
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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: 65 YR
• Patient Sex: Female