MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Burn(s) (1757); Skin Infection (4544)

Event Date 10/07/2017

Event Type  Injury  

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The reported complaint is related to skin irritation.Dose audit and environmental monitoring reports were reviewed for issues relating to sterility of the product.The sensor component has no impact on product sterility and therefore, sensor components dhrs were not reviewed.Sensor kit dhrs have been reviewed to assess the manufacturing process, which includes the application of the adhesive to the puck.A dhr (device history review) for the freestyle libre sensor kit was reviewed and the dhr showed the freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.The dose audit report covers the required time period.A tripped trend review was completed for the reported complaint and freestyle libre sensors and no trips were observed.Complaint data analysis has been reviewed for this product and issue.No adverse trends have been identified.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported experiencing an infection while wearing an adc freestyle libre sensor.Customer further reported that after 7 days of wear, he "felt the skin burning and a rash" and noticed "the skin was burned until the elbow".Customer had a friend remove the sensor after 10 days of wear due to discomfort and upon removal, customer noted "the skin was ripped off" and the skin had "been detaching all over the upper arm".Customer further noted "2nd degree burning, blister with liquid, and infected skin" and an abscess at the insertion site.Customer had contact with a healthcare professional and was provided flammazine (topical antibiotic) for treatment.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 11398427
• MDR Text Key: 234231574
• Report Number: 2954323-2021-05590
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention