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

Model Number	102620-67A
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021,senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
The sensor was investigated, and though the issue couldn't be reproduced, the customer's complaint of an esr (ec#1) was however confirmed via dms' in-vivo data review.The root cause to this failure is potentially an insufficient in-vivo hydration of the sensor's hydrogel after insertion.The investigation shows the system correctly disabled the sensor due to performance failure and the system's self-test functions are working normally.As part of resolution, the rma was authorized to offer the user a sensor replacement.D9 device available for evaluation? yes, device received on 14 dec 2021.H3.Device evaluated by manufacturer?yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 3231.H6.Investigation conclusions updated to 4307.

• 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: 12944843
• Report Number: 3009862700-2021-00142
• Device Sequence Number: 4912098
• Product Code: QCD
• 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: 2021
• 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): 11/06/2021

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: 04/15/2022
• Device Model Number: 102620-67A
• Device Catalogue Number: FG-4201-00-301
• Device Lot Number: WP08306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2021
• Supplement Date Received by Manufacturer: 11/06/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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: 79 YR
• Patient Sex: Male