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	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Senseonics was made aware of an incident where the user reported an event where the system triggered a false low glucose alert when the bg was 84 mg/dl and sg was 48 mg/dl at 10 am on (b)(6) 2024.A review of the data management system (dms) data confirmed that the sg value was 48 mg/dl and no bg was entered in the system.A review of the alert history revealed that the user received a low glucose alert at 09:58 am.User didn't seek for medical treatment and mentioned that he was not having a low glucose event.
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 experiencing hyperglycemic event on (b)(6) 2024.The user mentioned that the bg at the time was 86 mg/dl and sg was 46 mg/dl.A review of the data management system (dms) data revealed that on (b)(6) 2024 at 9:58 am ct sg was 43 mg/dl, and no bg was entered.A review of the alert history revealed that the user did receive a low glucose alert at 9:58:42 am cst, when the sg was at 43mg/dl.User did not seek medical treatment and believed that they were not having a low glucose event.User's hcp was not aware of the event.The user was advised to follow up with their hcp for any necessary medical guidance.In an associated case for the user's complaint about sensor inaccuracy (complaint (b)(4)), an initial review of the system revealed some differences between sg and bg values, potentially due to early wear.It is expected to see some differences during the initial days of the use, as the system is stabilizing after insertion.The user was advised to continue using the system, entering calibrations when the glucose is stable, if possible.The user was also educated about lag and early wear period.The sensor is currently in use, and the system is displaying good agreement between the sensor readings and calibration entries.The root cause of the reported inaccuracy can be attributed to early wear adjustment.B4.Date of this report 06 december 2024.G3.Date received by the manufacturer? 06 december 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: 20768406
• Report Number: 3009862700-2024-01081
• Device Sequence Number: 20972672
• 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): 12/06/2024

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: 10/23/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 141552
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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: 70 YR
• Patient Sex: Male