MAUDE Adverse Event Report: ABBOTT DIABETES CARE LIMITED FREESTYLE LIBRE 14; SENSOR, GLUCOSE, INVASIVE

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

Patient Problems Itching Sensation (1943); Burning Sensation (2146)

Event Date 03/13/2019

Event Type  Injury  

Event Description

I have been using the freestyle libre 14 day for over 6 months with no issue at all.Now the last 6 sensors caused burn and itching on skin after just a couple of days and needed to be removed.Tried to call abbott.Was told adhesive has been changed.I have a picture of the product.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE LIMITED
• MDR Report Key: 8612004
• MDR Text Key: 145228713
• Report Number: MW5086638
• Device Sequence Number: 2
• Product Code: PZE
• Combination Product (y/n): Y
• 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: 05/13/2019
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR