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

Model Number	102620-81A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently waiting for information regarding next removal attempt.The additional information will be provided in a supplemental report.
Event or Problem Description
On 30 september 2024,senseonics was made aware of an incident where physician was unable to remove the sensor on the first attempt made on (b)(6) 2024.
Additional Manufacturer Narrative
Inability or difficulty to remove sensor during first attempt is a known and anticipated potential risk and eversense e3 user guide mentions about it under "risks and side effects".It was reported that the user's sensor could not be removed.The sensor was palpable and a magnet was used to locate the sensor.Customer care made multiple attempts to contact the hcp's office to gather additional information regarding the removal attempt, but no response was received.B4.Date of this report updated to 13 november 2024.G3 date received by the manufacturer ?22 october 2024.H3.Device evaluated by manufacturer? no.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING 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: 20564029
• Report Number: 3009862700-2024-01049
• Device Sequence Number: 7817256
• Product Code: QHJ
• UDI-Device Identifier: 00817491022967
• UDI-Public: 00817491022967
• 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): 11/13/2024

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
• Device Expiration Date: 12/06/2024
• Device Model Number: 102620-81A
• Device Catalogue Number: FG-7201-00-301
• Device Lot Number: 01E145S
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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: 45 YR
• Patient Sex: Female