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

Lot Number 190319P

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Discomfort (2330); Skin Inflammation (2443)

Event Date 06/07/2019

Event Type  Injury  

Event Description

I used the freestyle libre 14 day sensor.Within one day of applying it to my arm, the area became itchy and uncomfortable.I dealt with the itchiness, but after the 14 day use, i took it off to find a bright red, circle of inflammation where the sensor had been.This redness and itchiness did lessen (with it off) as days went by, but even after another 14 days, the mark was still visible.I did put another sensor on the other arm and the same thing happened on that arm.The first red circle was still visible after 28 days, but not as much.I tried the 14 day sensor three times, switching arms, but each time i had the same reaction.I never had this reaction with the 10 day sensor.This makes me think that the adhesive the company is using is different and obviously harmful to the skin based on my reactions.In my opinion, the company should use the same adhesive they used for the 10 day or create something new, so that others will not have the reactions i did.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8821780
• MDR Text Key: 152160328
• Report Number: MW5088302
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/19/2019

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: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Lot Number: 190319P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 82