MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 10 DAY SENSOR AND 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY CALIBRATED USER - INITIATED

Device Problems Product Quality Problem (1506); Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); No Code Available (3191)

Event Date 03/20/2019

Event Type  Injury  

Event Description

Serious skin rash and blistering with the libre sensor.It has worsened with each use since (b)(6) 2019, and this most recent sensor caused large blisters.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 10 DAY SENSOR AND 14 DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY CALIBRATED USER - INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8500773
• MDR Text Key: 141734638
• Report Number: MW5085745
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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 Age: 51 YR