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

Model Number	102620-81A
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On may 31, 2024, senseonics was made aware of an incident where the user received an early sensor replacement alert resulting in an early sensor removal.
Additional Manufacturer Narrative
The rma was authorized but not received, thus no confirmation or investigation of the complaint was possible.B4.Date of this report updated to 27 august 2024.G3.Date received by the manufacturer? 27 august 2024.H6.Type of investigation updated to 4114.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 67.

• 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: 19609937
• Report Number: 3009862700-2024-00781
• Device Sequence Number: 15036604
• 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): 08/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/17/2024
• Device Model Number: 102620-81A
• Device Catalogue Number: FG-7201-00-301
• Device Lot Number: WP09620
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Female