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	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, senseonics was made aware of a hypoglycemia 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 a low glucose event on october 18, 2023, at 4:39 pm.The sensor glucose (sg) at the time of the event was 149 mg/dl and the bg was 34 mg/dl.A review of glucose trend on october 18th, 2023, confirms the complaint, as the sg= 149 mg/dl on 18 oct 2023, 4:36 pm and bg (logged as suspicious fingerstick) = 34 mg/dl on 18 oct 2023, 4:39 pm.The user did not receive the low glucose alert due to the sg level being above the low alert limit of 75 mg/dl.The user did not seek medical treatment and was able to treat himself for the event but was advised to contact hcp for any medical assistance.In an associated complaint for sensor inaccuracy (complaintrec-43378), it was determined that the system was experiencing some instability, and eventually the system triggered a sensor replacement alert on 19 october 2023, which was address as part of complaintrec-43489, (mfr report #3009862700-2023-01029).A return material authorization (rma) was issued to offer the user a sensor replacement.Investigation results on the returned sensor revealed a loss of chemical performance.The system correctly disabled the sensor when it detected the performance failure, and the system's self-test functions were working normally.The root cause of the performance failure was due to oxidation of the chemical component of the sensor.B4.Date of this report updated to 26 december 2023.G3.Date received by manufacturer updated to 01 december 2023.H3.Device evaulated by manufacturer? yes.H6.Investigation findings updated to 3231.H6.Investigation conclusions updated to 4307.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 18166969
• Report Number: 3009862700-2023-00212
• Device Sequence Number: 6646748
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• 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): 12/26/2023

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: 08/15/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 131252
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 11/19/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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: 39 MO
• Patient Sex: Male