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

Model Number 71953-01

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  Injury  

Manufacturer Narrative

This is an initial final report.This complaint was received via user report and has been reported to fda.The report was a product request.At this time product has not yet been returned and a valid serial number has not been provided.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: "recall on device.They will not replace.Device on recall.Called 3 times.They will not replace it.Freestyle libre 2".The customer was requesting a replacement device and no further information was provided.There was no report of any self or third-party medical treatment reported.No contact information was provided to adc therefore on the user report therefore, adc is unable to contact the customer to gain additional information.Based on the information provided, there was no report of serious 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: 17266163
• MDR Text Key: 318492797
• Report Number: 2954323-2023-28999
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1