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

Model Number	102812-81A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	01/13/2025
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 21 jan 2025, senseonics was made aware of an incident where user reported of being hospitalized for being sick and lost consciousness and has no recollection of the time of the event and per user's daughters confirmation that the user was diagnosed with mrsa(methicillin-resistant staphylococcus aureus).The user received a surgical procedure as treatment at the hospital.The user was prescribed with medication.
Additional Manufacturer Narrative
The user reported a serious adverse event where the user was hospitalized from 13 jan 2025 till 19 jan 2025.Per case notes, the user was sick and lost consciousness.User could not recollect time of event.The user's daughter reported that the user was diagnosed with methicillin-resistant staphylococcus aureus (mrsa) infection, which is unrelated to eversense system.The user received a surgical treatment at the hospital and was prescribed with medication.Since the event was not related to diabetes or eversense cgm system, no further investigation was found necessary for this complaint.B4.Date of this report 06 march 2025.G3.Date received by the manufacturer? 06 march 2025.H6.Health effect -impact code updated to 4614.H6.Component code updated to 4756.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 4310.

• 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: 21426815
• Report Number: 3009862700-2025-00245
• Device Sequence Number: 18121032
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 00817491022974
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/06/2025

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: 05/02/2025
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: 01E241S
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female