MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 102208-500

Device Problem Temperature Problem (3022)

Patient Problems Burn(s) (1757); Discomfort (2330)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

No further information was provided by the user.Hence,no further investigation can be performed.

Event Description

On (b)(6) 2020,senseonics was made aware of an adverse event that user has a burn on her arm from the transmitter.

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 TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown,, md
• MDR Report Key: 9760297
• MDR Text Key: 183770774
• Report Number: 3009862700-2020-00184
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/18/2019
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 111520-C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR