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	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is a result of retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On october 25, 2023, senseonics was made aware of an adverse event where user reported hypoglycemic event with no alert from the system due to sensor inaccuracy.User resolved the issue by drinking apple juice.
Additional Manufacturer Narrative
Customer reported a low glucose event: sg = 187 mg/dl, bg = 40 mg/dl on (b)(6) 2023, 2.05 am, sg = 169 mg/dl, bg = 34 mg/dl on (b)(6) 2023, 2.10am.A review of glucose trend on (b)(6) 2023 revealed sg = 187 mg/dl, on (b)(6) 2023 at 2.05 am, sg = 169 mg/dl, on (b)(6) 2023 at 2.10am.However, the bg values were not entered.Hence, the reported mismatch could not be confirmed.The user did not seek medical treatment and was able to treat himself by drinking apple juice.Based on the initial escalation analysis, the sensor performance deviated from normal behavior.The rma was authorized due to the deviation in sensor performance where there was mismatch observed between the sensor readings and calibration entries.Sensor (b)(4) was tested in-house, and a qc did not reveal any malfunction of the sensor.However, review of dms data revealed that there was dip in reference and signal coincide directly with the covid diagnosis and start of treatment and the sensor is taking longer than expected to settle.A review of the raw data revealed that there was dip in reference and signal channel values which coincided with the start of her covid treatment with paxlovid.There is currently no data confirming paxlovid has any interference with sensor readings.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10; 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: 18252944
• Report Number: 3009862700-2023-00217
• Device Sequence Number: 15232770
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• 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): 12/01/2023

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: 09/26/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 132235
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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: 61 YR
• Patient Sex: Female