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

Model Number 71992-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 09/12/2020

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

Customer reported being unable to position the freestyle libre 2 sensor correctly upon application.Customer further reported requiring third-party treatment, however no further details were provided and attempts to gather additional information have been unsuccessful thus far.There was no report of death or permanent impairment associated with this event.

Event Description

Customer reported being unable to position the freestyle libre 2 sensor correctly upon application.Customer further reported requiring third-party treatment, however no further details were provided and attempts to gather additional information have been unsuccessful thus far.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Section h4 (device mfg date) were 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.Dhrs (device history review) for the fs libre sensor kit was reviewed and the dhrs showed the fs libre sensor kit passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed.

• 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: 10900859
• MDR Text Key: 218203665
• Report Number: 2954323-2020-11818
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention