MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

This is an initial final report.This complaint was received via user report and has been reported to fda.Further investigation is not anticipated as customer indicated this was a product suggestion.If additional information is obtained, a follow-up report will be submitted.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.N/a was selected for g4 - pma/510(k) # as it is unknown if the user was using android, ios, or a fs libre reader with the fs libre 3 sensor.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: a customer stated their displeasure with the adc device (freestyle libre 2 and freestyle libre 3 systems) having an alarm feature (to alert of high or low glucose).The customer stated that they found the alarms too loud and disruptive and expressed sentiment that they did not like the alarm feature.Please note that the alarm feature can be turned off.The customer was contacted and stated they did not require further assistance as they already made their suggestions, and the customer did not report of this feature causing adverse event or third-party intervention.Based on the information provided, there was no report of serious injury associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16376672
• MDR Text Key: 309548800
• Report Number: 2954323-2023-06799
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male