MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number	102812-81A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer is currently performing evaluation and the results will be provided in the supplemental report.
Event or Problem Description
On 13 nov 2024, senseonics was made aware of an incident where patient reported that the sensor broke during removal procedure.The event happened on (b)(6) 2024 at approximately 3:00 pm.The hcp attempted to remove the sensor with the clamps provided in the custom vygon procedure kit, and the distal tip of the sensor broke off.The sensor had been implanted in the upper arm.All the pieces of the broken sensor were successfully removed.
Additional Manufacturer Narrative
According to the case information, it was reported that the sensor broke during the removal procedure.The hcp was able to successfully remove all the pieces of the broken sensor.A return material authorization (rma) was issued for the return of the device for further investigation.However, the device was not returned at the time of closure of this complaint.Additionally, no images were provided for visual confirmation of the sensor breakage.The potential root cause of fracture of sensor during removal is usually excessive force on the removal clamps/pliers grabbing an extremity or part of the sensor.In some cases, the patient's tissue at insertion sites may encapsulate the sensor, obstructing its removal.The doctor may then attempt excessive force on the clamps and risk fracturing the sensor.Sensor breakage during removal is a known and anticipated potential adverse effect, which is stated in the eversense e3 user guide under "risks and side effects" section.No further investigation was found necessary.B4.Date of this report 27 december 2024 g3.Date received by the manufacturer? 27 december 2024 h3.Device evaluated by manufacturer? no h6.Type of investigation updated to 4114 h6.Investigation findings updated to 3221 h6.Investigation conclusions updated to 4311.

• Brand Name: EVERSENSE SENSOR
• 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: 20917896
• Report Number: 3009862700-2024-01125
• Device Sequence Number: 14713163
• 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): 12/27/2024

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: 07/05/2024
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09715
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male