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	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 25, 2024, senseonics was made aware of an event where the user experienced a hyperglycemia event with no alert from the system due to sensor inaccuracy.
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 at 10:30 am.The user mentioned that the bg at the time was 410 mg/dl, while the system was showing that the glucose level was stable.A review of the data management system (dms) data revealed that the sg value at 10:27 am was 79 mg/dl and no bg value was entered.The user didn't receive high glucose alerts at the reported time as the sg never went above the high alert threshold.The issue happened when user was at hcp location.The hcp gave a treatment plan for the user to take 5 units of insulin every time she eats and to take 50 units of insulin before bed each night.In an associated case for the user's complaint about sensor inaccuracy, initial review of the system revealed that the user was entering estimated values provided by the app as calibrations rather than true bg values.The user was advised that they should never enter anything other than a true bg meter value, from a finger stick, when calibrating.The user understood the advice and started entering true fingerstick values while calibrating the system.An additional review of the system after the event revealed that sg values were in good agreement with bg values entered, trends well, with occasional differences due to lag and calibrations entered during periods of rapid change in glucose.The user did not report any additional inaccuracies since this event.B4.Date of this report 22 november 2024.G3.Date received by the manufacturer? 22 november 2024.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 19.

• 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: 20296017
• Report Number: 3009862700-2024-00945
• Device Sequence Number: 12565114
• 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): 11/22/2024

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: 08/25/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 69 YR
• Patient Sex: Female