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	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On june 5, 2024, senseonics was made aware of an event where the user reported a hypoglycemic event with no alert from the system.The user didn't seek medical treatment and resolved the event by drinking apple juice.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
The customer reported the following low glucose values: sg = 106 and bg = 47 mg/dl on (b)(6) 2024, 12:11 am.A review of the data management system (dms) confirmed the reported bg and sg values on (b)(6) 2024, at 12:11 am.The calibration entered by the user was rejected by the system.Glucose alert settings were provided as follows: low alert: 80 mg/dl.High alert: 220 mg/dl.Dms review confirmed that the user didn't receive a low glucose alert at the time of the event because the sg values never went below the low alert setting of 80 mg/dl.The customer did not seek medical treatment and treated himself by drinking apple juice.User's hcp was not aware of the event.The user was advised to get in touch with their hcp for medical guidance.The difference observed between sg and bg readings was addressed under an associated sensor inaccuracies case (mdr# (b)(4)).Initial escalation analysis determined that the sensor deviated from its normal behavior, however root cause could not be determined based on the available data.Hence, an rma (return material authorization) was authorized for further investigation of the sensor.B4.Date of this report: (b)(6) 2024.G3.Date received by the manufacturer? 18 july 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: 19670355
• Report Number: 3009862700-2024-00794
• Device Sequence Number: 19611894
• 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): 07/18/2024

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: 01/16/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 135515
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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