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

Model Number	101368-67A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/23/2020
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 july 23rd 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
Follow up on the sensor removal status was not possible due to non-response from the user.The high rate of inability to remove sensor is being addressed under corrective and preventive action.No further investigation was found necessary.H6 result code updated to 3221.H6 conclusion code updated to 67.
Additional Manufacturer Narrative
The sensor was successfully removed during the second removal attempt.The high rate of inability to remove sensor is being addressed under corrective and preventive action.No further investigation was found necessary.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 10440436
• Report Number: 3009862700-2020-00464
• Device Sequence Number: 3974668
• Product Code: QCD
• UDI-Device Identifier: 00817491021410
• UDI-Public: 00817491021410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

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: 10/24/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP05150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020; 07/23/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/02/2020; 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR