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

Model Number	102812-67A
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is result of a retrospective review of complaints.Based on the initial analysis, the rma was authorized due to possibility of damage in the optical channel.Damage to optical channel was suspected since raw sensor data in dms showed very little modulation on signal channel.The potential cause of such behavior may be due to lack of hydration of the hydro-gel after insertion.Upon receipt of the rma, the sensor was tested in-house, and the review of qc data did not reveal any malfunction of the sensor.The issue observed in the field, could not be reproduced during the qc in-vitro testing.As part of resolution, the rma was authorized to offer the user a sensor.Replacement.
Event or Problem Description
On (b)(6) 2021,senseonics was made aware of an incident where user experienced inaccuracies in sensor readings which leads to early sensor removal.

• 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: 13056140
• Report Number: 3009862700-2021-00166
• Device Sequence Number: 3902836
• Product Code: QCD
• UDI-Device Identifier: 00817491022523
• UDI-Public: 00817491022523
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 102812-67A
• Device Catalogue Number: FG-4202-00-301
• Device Lot Number: WP08306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 12/21/2021
• 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: 49 YR
• Patient Sex: Male