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

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Skin Irritation (2076); Partial thickness (Second Degree) Burn (2694)

Event Date 08/06/2019

Event Type  Injury  

Event Description

Using freestyle libre system.Developed a dermatitis mild from the very first sensor used on my left arm after only 8-9 days.The sensor came off early.I got a second degree burn from the adhesive for the second sensor after 9 days of use.It was hidden under the sensor, and there was no pain.It blistered up and turned red and weep for about a week.It is still not all the way healed and i may end up with a scar about 2.5 cm in diameter on my upper arm due to this reaction.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 8927193
• MDR Text Key: 155517987
• Report Number: MW5089274
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 109