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

Model Number 102096-67A

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On november 26th 2020, senseonics was made aware of an adverse event where the physician was unable to remove the sensor on the first attempt made.

Manufacturer Narrative

The sensor was successfully removed during the second removal attempt on (b)(6) 2021.The high rate of inability to remove sensor was addressed under (b)(4) which was closed per (b)(4).No further investigation was found necessary.D6b.Explanted date updated to (b)(6) 2021.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 4311.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 11073257
• MDR Text Key: 223785200
• Report Number: 3009862700-2020-00586
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): Y
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07579
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR