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

Model Number FREESTYLE LIBRE 14 DAY

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Irritation (1941); Partial thickness (Second Degree) Burn (2694)

Event Date 03/20/2020

Event Type  Injury  

Event Description

Blistering and severe irritation at the attachment site of the 14 day freestyle libre glucose sensor.This has been happening since they switched me to the 14 day sensor from the 10 day sensor.I get severe itching while wearing the sensor and then when removed there is a severly irritated, red and inflamed mark that last 5 to 6 weeks after removal of the sensor.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 INC.
• MDR Report Key: 9877617
• MDR Text Key: 185050547
• Report Number: MW5093910
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00357599001018
• UDI-Public: (01)00357599001018
• 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: 03/20/2020

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: 07/31/2020
• Device Model Number: FREESTYLE LIBRE 14 DAY
• Device Catalogue Number: 71940-01
• Device Lot Number: 191202P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 108