MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY - CALIBRATED, USER-INITIATED

Model Number FREESTYLE LIBRE 14

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943); Rash (2033)

Event Date 05/01/2019

Event Type  Injury  

Event Description

I experienced a bad skin reaction that took several days to heal after wearing the abbott freestyle libre 14 day diabetes sensor - cms (continuous monitoring system).Over the past month i have experienced itching along with a circular red rash and skin irritation after each application of the freestyle libre 14 sensor.The irritation is due to the adhesive that is currently being used in the product.This is a product change as i experienced no symptoms with the freestyle libre 10 sensor.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY - CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8703672
• MDR Text Key: 148279797
• Report Number: MW5087386
• Device Sequence Number: 1
• Product Code: PZE
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: FREESTYLE LIBRE 14
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 65