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	09/09/2024
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 september 12, 2024, senseonics was made aware of an incident where the user experienced a hypoglycemia event with no alert from the system.
Additional Manufacturer Narrative
The user reported a low glucose event on (b)(6) 2024 around 05:42pm.The user mentioned that the sg at the time was 115 mg/dl while the bg was 44 mg/dl.A review of the dms data revealed that the sg value was 117 mg/dl at 6:43 pm and bg was 44 mg/dl at 6:42 pm.The user did not receive any low glucose alert at the time of event because the sg never went below the low glucose alert level.The user did not seek medical treatment and resolved the event by eating something.A review of the dms data showed significantly low signal and reference channel values and declining sensor performance since insertion.It was determined that the sensor had deviated from its normal behavior and a sensor replacement was offered to the user due to system performance, which was document under complaint: (b)(4) (mfr#: 3009862700-2024-00961) further investigation on the sensor and the results will be reported under complaint: (b)(4).B4: date of this report 25 october 2024.G3: date received by the manufacturer? 21 october 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: 20434210
• Report Number: 3009862700-2024-00986
• Device Sequence Number: 7626556
• 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): 10/25/2024

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: 09/11/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 140365
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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
• Patient Age: 49 YR
• Patient Sex: Female