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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Swelling (2091)

Event Date 03/15/2019

Event Type  Injury  

Event Description

The free style libre 14-day glucose system sensor adhesive caused significant reaction on my skin that took weeks to clear.The sensor was applied following the directions, including clearing with an alcohol wipe, itching, blistering, redness, and swelling resulted.After a couple of weeks i tried to apply another sensor on the other arm and got the same result.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14-DAY GLUCOSE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD.
• MDR Report Key: 8591181
• MDR Text Key: 144532275
• Report Number: MW5086449
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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