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

Model Number	102620-67A
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
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 sept 04th 2020,senseonics was made aware of an incident where user received a "new sensor detected" alert when preparing the user while troubleshooting a diiferent case of "no sensor detected" alert.It was confirmed that the transmitter is detecting both the previous sensor and the new one, preventing the system from working properly, resulting in sensor removal.
Additional Manufacturer Narrative
The case was escalated to next level support team and based on additional case escalation and review of the diagnostic upload, it was confirmed that the user's transmitter was detecting both the previous transmitter and the new one, preventing the system from working properly.The recommendation from the escalation team is to have both sensors, new and previous, removed and another sensor inserted.Senseonics would cover the costs for sensor replacement and procedure.No investigation was found necessary for this complaint.

• 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
• MDR Report Key: 10624511
• Report Number: 3009862700-2020-00511
• Device Sequence Number: 2604161
• 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: 2020
• 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): 09/04/2020

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: 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
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR