MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number	102208-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/30/2024
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 03 october 2024, senseonics was made aware of an event where the user reported experiencing a low glucose event that caused him to become unconscious and ambulance was called.The issue happenend on (b)(6) 2024 around 02:40 pm.The user mentioned that the sg at the time of the event was 70 mg/dl while the bg was 28 mg/dl.A review of the dms data revealed that the sg value was 79 mg/dl at 02:40 am and bg was not entered.The user didn't receive a low glucose alert at the time of event because the sg never went below the alert level.The user received an iv as treatment by the ambulance.The user wasn't prescribed medication.
Additional Manufacturer Narrative
The user reported a hypoglycemic event on 30-sep-2024 around 2:40 pm which led to unconsciousness, and he wasn't aware when the ambulance was called.The following example set was provided related to the hypoglycemia event where sg 70 mg/dl and bg 28 mg/dl on 30 september 2024 around 02:40 am.A review of the data management system (dms) data was performed, and it showed that on (b)(6) 2024 at 2:39 am user's sg value was 79 mg/dl, and no bg value was entered.After dms review, it was confirmed that the user didn't receive a low glucose alert at the time of the event because the sg was above the low alert threshold level.As per case notes, the user received iv treatment by the ambulance.The user wasn't prescribed any medication.The user's hcp was not aware of the event, and the user was advised to follow up with the hcp for further medical guidance.In an associated complaint from the user for sensor inaccuracy, it was observed that overall, the bg values matched sg trends well, with some occasional differences due to lag time between changes in blood glucose and sensor readings.At the time of the event, the glucose was changing rapidly, which can potentially make the system more susceptible to lag.The user was advised to continue using the system entering calibrations when the glucose is stable.The user was satisfied with the information given.The sensor is currently in use, and the system is displaying good agreement between the sensor readings and calibration entries.B4.Date of this report updated to (b)(6) 2024.G3 date received by the manufacturer? 11 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: 20594757
• Report Number: 3009862700-2024-01030
• Device Sequence Number: 8943062
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 00817491022929
• 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): 11/15/2024

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: 10/09/2024
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 141133
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 11/02/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male