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	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On april 24, 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 taking glucose tabs and eating.
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 = not provided and bg = 35 mg/dl on (b)(6) 2024, between 4.00am to 5.00am dms review showed: sg = 146 mg/dl and bg was not entered on (b)(6) 2024, 4.03 am sg = 135mg/dl and bg was not entered on (b)(6) 2024, 5.03 am the customer reported mismatches could not be confirmed as user did not provide any sg value and the reported bg values were not entered into the system.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 60 mg/dl.The customer did not seek medical treatment and treated himself by consuming glucose tabs and eating.In associated sensor inaccuracies case, it was determined the system is working within expectations.Overall, bg values entered as calibrations fit sg trends well, with occasional differences due to lag, and calibrations entered during periods of rapid change in glucose.In follow up call with the user, the user agreed with this information, confirmed everything is working fine and had no other concerns.The user is currently using the system.No further investigation was found necessary for this complaint.Date of this report 07 june 2024 date received by the manufacturer? 07 june 2024 investigation findings updated to 114 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: 19389024
• Report Number: 3009862700-2024-00708
• Device Sequence Number: 6946304
• Product Code: QHJ
• UDI-Device Identifier: 00817491022936
• UDI-Public: 00817491022936
• 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): 06/07/2024

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: 03/10/2023
• Device Model Number: 102208-620
• Device Catalogue Number: FG-5902-01-001
• Device Lot Number: 129542
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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: 74 YR
• Patient Sex: Female