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

Lot Number G02

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

Patient Problems Burn(s) (1757); Erythema (1840); Skin Irritation (2076); Swelling (2091); Skin Inflammation (2443)

Event Date 05/08/2020

Event Type  Injury  

Event Description

The freestyle libre sensor has been used for over a year with no problem.Starting sometime in (b)(6), the disk would come off sooner that it should (it lasts 2 weeks before replacement), and underneath the disk, in the exact shape of the disk, was an acid like burn on the skin of the arm.It consisted of bright red, blistered, raised lesions on the skin in the exact circle of the disk.This has happened four times, with four different disks.In calling the company, they said that sometimes they change the adhesive to make it more sticky.Whatever they've changed it to is causing the skin to be greatly compromised.The most recent disk had sn (b)(4) expiring 8-31-2020.The patient has nka and can use any bandaid without issue; no latex allergy.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10074803
• MDR Text Key: 191816254
• Report Number: MW5094574
• Device Sequence Number: 3
• 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: 05/15/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: G02
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 91