MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR

Model Number	102208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Senseonics was made aware of an incident where user reported a low glucose event on 22 jan 2025 where user's sg was out of range and bg was 206 mg/dl.After dms review, we confirmed that the user received a low glucose alert at 9:11 am, when the sg was at 42 mg/dl.Prior to that, there was no sg data between 8:45 am ct to 9:11 am ct because it was out of range, and before that the user had been receiving low glucose alerts every 15 minutes.The user didn't seek for medical treatment and didn't need to treat himself because it wasn't a real low glucose event, which the user confirmed by checking his bg at the time.The user's hcp isn't aware of the event and was advised to follow up with the hcp for further medical guidance.
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 (b)(6) 2025 9:08 am cst where sg out of range low and bg 206 mg/dl.A review of the data management system (dms) data revealed that on (b)(6) 2025 at 9:08 am cst bg was 206 mg/dl and the user's sg was 42 mg/dl at 9:11 am cst.A review of the alert history revealed that the user received multiple low glucose alerts since (b)(6) 2025, 9:05 pm cst through (b)(6) 2025, 12:26 pm cst, as user's sg value was below the threshold of 65 mg/dl.User did not seek medical treatment and believed that they were not having a low glucose event.User's hcp was not aware of the event.The user was advised to follow up with their hcp for medical guidance.An case (b)(4) was created to address the sensor's inaccuracies inclusive of the event and under this case it was determined that the sensor had deviated from normal behavior and an rma was issued for further investigation.However, the sensor was not returned to senseonics by the closure of this complaint.A review of the in vivo raw data showed instability in signal and reference channel values on the (b)(6) 2025.The instability most likely contributed to the inaccuracies observed.The sensor was not returned to senseonics by the closure of this complaint.Per case notes, the user's hcp informed customer care on (b)(6) 2025 that the user will continue using the system.Review of dms showed that the optical instability recovered around (b)(6) 2025 onwards and the system showed better sg/bg accuracy.The user continued using the system up until normal sensor 180-day retirement on (b)(6) 2025, with no further inaccuracy cases.B4.Date of this report 12 may 2025.G3.Date received by the manufacturer? 12 may 2025.H3.Device evaluated by manufacturer? yes.H6.Health effect - clinical code updated to 4582.H6.Component code updated to 510.H6.Type of investigation updated to 4121.H6.Investigation findings updated to 3224.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 21439044
• Report Number: 3009862700-2025-00094
• Device Sequence Number: 14540153
• 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): 05/12/2025

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: 08/28/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 139968
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male