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

Model Number	102620-67A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/31/2020
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 august 31st 2020, senseonics was made aware of an adverse event where physician was unable to remove the sensor in the first attempt made.
Additional Manufacturer Narrative
Despite multiple follow up attempts with the user the removal status of the sensor could not be confirmed.Since the user was not responsive the complaint could not be confirmed.No further investigation is required.D2.Product code updated to qhj.H3.Device evaluated by manufacturer? no, other.H6.Investigation findings updated to 3233.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 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 10609808
• Report Number: 3009862700-2020-00501
• Device Sequence Number: 3985035
• Product Code: QHJ
• UDI-Device Identifier: 00817491022356
• UDI-Public: 00817491022356
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020
• 2 Devices were Involved in the Event: 1 2

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: 11/21/2020
• Device Model Number: 102620-67A
• Device Catalogue Number: FG-4201-00-301
• Device Lot Number: WP07591
• 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: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2019
• 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
• Patient Age: 45 YR
• Patient Sex: Male