MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

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

Patient Problem Bruise/Contusion (1754)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported experiencing bruising while wearing an adc freestyle libre 2 sensor and having contact with a friend, who is an hcp, who prescribed heparin gel for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: h4 - (device mfg date) has been updated based on extended investigation.No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specifications.The dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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 products.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.If the product is returned, a physical investigation will be performed and a follow-up report submitted.

Event Description

A customer reported experiencing bruising while wearing an adc freestyle libre 2 sensor and having contact with a friend, who is an hcp, who prescribed heparin gel for treatment.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 11009027
• MDR Text Key: 221459063
• Report Number: 2954323-2020-13363
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention