MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE

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

Patient Problems Itching Sensation (1943); Swelling (2091); Reaction (2414)

Event Type  Injury  

Event Description

Have been using the 14 day libre sensor and have had a reaction to the adhesive.The adhesive must have changed because i had no issue until the last 3 sensors.The sore is round and causes almost like a chemical burn.The sore itches and takes weeks to go away with antibiotic cream.Fda safety report id# (b)(4).

• Brand Name: LIBRE 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 9172265
• MDR Text Key: 161783370
• Report Number: MW5090283
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 86