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

Model Number 102096-67A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

The patient was prescribed with medication.No further investigation can be performed.

Event Description

On (b)(6) 2020,senseonics was made aware of an adverse event where the whole patch area where the sensor was inserted was all red and blistered and fuzzy from the skin peeling off.

Manufacturer Narrative

Despite of good faith efforts an additional followup was performed for additional information as requested by fda.However,there was no response and no additional information was provided by the user.No further investigation is possible.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown,, md
• MDR Report Key: 9760592
• MDR Text Key: 183771704
• Report Number: 3009862700-2020-00187
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): N
• 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: 01/27/2020

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: 07/03/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP06798
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR