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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burning Sensation (2146)

Event Date 09/05/2019

Event Type  Injury  

Event Description

After almost a year of using the freestyle libre, the sensor started burning my arm.The dr confirmed the burn and indicated i was probably allergic to the adhesive on the sensor.I found out that the company has changed the adhesive previously used on the sensors and that many others are suffering similar injury.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT DIABETES CARE LIMITED
• MDR Report Key: 9341480
• MDR Text Key: 167149227
• Report Number: MW5091159
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 84