MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 10-DAY SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Overheating of Device (1437)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 12/05/2018

Event Type  Injury  

Event Description

Reaction to freestyle libre 10-day sensor.Looks like a 2nd/3rd degree burn.This was my 4th and 5th sensor.Can supply pictures.Did the problem stop after the person reduced the dose or stopped taking or using the product? yes; did the problem return if the person started taking or using the product again? yes.Reason for use: diabetes, for glucose monitoring.

• Brand Name: FREESTYLE LIBRE 10-DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8138466
• MDR Text Key: 129507035
• Report Number: MW5081866
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; JANUMET XR; LOSARTAN ; ONE A DAY WOMEN'S; TRULICITY
• Patient Age: 46 YR
• Patient Weight: 52