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

Model Number 71992-01

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2021

Event Type  Injury  

Event Description

A customer reported an unspecified issue with freestyle libre 2 sensor insertion, and stated that the sensor didn't work.The customer reported they were currently at a hospital and required treatment, but did not provide any other information.Attempts to gather additional information have thus-far been unsuccessful.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing 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 an unspecified issue with freestyle libre 2 sensor insertion, and stated that the sensor didn't work.The customer reported they were currently at a hospital and required treatment, but did not provide any other information.Attempts to gather additional information have thus-far been unsuccessful.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unknown.¿ repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report.A valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

The serial number of the freestyle libre sensor associated with this complaint is unknown.During investigation of the track and trend review related to sensor insertion issues in january 2021, a failure mode was identified for a specific population of sensors.As the serial number of the sensor associated with this complaint is unknown, abbott diabetes care is unable to determine if this particular sensor was impacted by the observed manufacturing issue.Outside of the known manufacturing issue the available tripped trend reports for libre sensor and insertion 6 have been reviewed.The review did not identify any additional trends that would indicate a product related issue related to this complaint.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported an unspecified issue with freestyle libre 2 sensor insertion, and stated that the sensor didn't work.The customer reported they were currently at a hospital and required treatment, but did not provide any other information.Attempts to gather additional information have thus-far been unsuccessful.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 12802862
• MDR Text Key: 280684157
• Report Number: 2954323-2021-92390
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• 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: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male