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

Model Number	102208-620
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On december 5, 2023, senseonics was made aware of an adverse event where an ambulance was called and the user was hospitalized due to a hypoglycemia event without an alert from the system allegedly 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 passed out and was hospitalized due to a hypoglycemia event.The user reported 112 mg/dl sg on (b)(6) 2023 at 5:30pm cst, with 30mg/dl bg later at the hospital.Review of the glucose trend data confirmed sg = 112 mg/dl on (b)(6) 2023 5:31pm cst and the bg was not entered.A low glucose alert was not asserted at the time of the event due to the sg never reaching the low glucose alert setting of 65 mg/dl.The customer was treated with a bag of glucose intravenously to raise their glucose levels.From an associated s4 case#: (b)(4), it was observed that the user's past calibration entries were consistent with situations where estimated values provided by the app are used instead of the user's true bg values.Entering anything other than a true bg value can disrupt the calibration and lead to significant deviations in the sensor readings displayed, and this can have an impact for several days after resuming normal calibration.The user is doing fine and is currently using the system.No further investigation was found necessary for this complaint.B4.Date of this report 12 february 2024.G3.Date received by manufacturer 18 january 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 4109, 4111.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 18.

• 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: 18352752
• Report Number: 3009862700-2023-00839
• Device Sequence Number: 8407210
• Product Code: QHJ
• UDI-Device Identifier: 00817491022936
• UDI-Public: 817491022936
• 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): 02/12/2024

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: 12/19/2023
• Device Model Number: 102208-620
• Device Catalogue Number: FG-5902-01-001
• Device Lot Number: 134479
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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: 68 YR
• Patient Sex: Female