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 07/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On july 26th 2021, senseonics was made aware of an adverse event where physician was unable to remove the sensor on the first attempt made.

Manufacturer Narrative

H10: manufacturer narrative corrected to,"user mentioned that he had an appointment on (b)(6) 2021 to remove the sensor.Multiple follow up attempts were made to verify if the sensor was removed.However, user could not be reached.The high rate of inability to remove sensor was addressed under capa-0104 which was closed per ntf-0404.No further investigation was found necessary".

• 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: 12318959
• MDR Text Key: 266414592
• Report Number: 3009862700-2021-00100
• 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: 07/26/2021

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: 08/29/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07386
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR