MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD. FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM SENSOR SENSOR, GLUCOSE, INVASIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Rash (2033); Tissue Breakdown (2681)

Event Date 10/02/2018

Event Type  Injury  

Event Description

I use the libre sensors and for the past couple months whenever i put them on, i develop major itching, a rash and blisters. The sensors are supposed to stay on for 14 days, but after 3 days i have to remove it. I've been using a skin barrier to help protect my skin, but whatever is on the sensors to make them stick eats through the barrier. I don't know what is causing this but i still have wound marks left by the sensors. Date the person first started taking or using the product: (b)(6) 2017; to monitor blood sugar levels in type 1 diabetic.

• Brand Name: FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD.
• MDR Report Key: 8133324
• MDR Text Key: 129468805
• Report Number: MW5081829
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 12/04/2018 Patient Sequence Number: 1