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

Model Number	72077-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Abbott diabetes care received a medwatch report which reported the following information pertaining to an abbott diabetes care (adc) device: a customer reported that they tried three times to link their iphone.The customer called the adc customer service and was told to download another app, which stated that it was incompatible.They were advised to put a new sensor.There was no report of adverse heath impact and any self or third-party medical treatment.No contact information was provided to adc; therefore, adc is unable to attempt any follow up activities related to this event.Based on the information provided, there was no report of serious injury associated with this event.
Additional Manufacturer Narrative
This complaint was received via user report and has been reported to fda.An investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
An investigation was performed for the reported complaint.The customer reported for unable to connect with the app due to incompatibility issue.Attempt to identify the customer's reported configurations and the information provided in the complaint was insufficient to conduct a comprehensive investigation.The lack of information regarding the app version and the os, restricts the ability to identify potential causes of the customer's reported issue.Therefore, the reported issue is not confirmed due to the inadequate information provided.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care received a medwatch report which reported the following information pertaining to an abbott diabetes care (adc) device: a customer reported that they tried three times to link their iphone.The customer called the adc customer service and was told to download another app, which stated that it was incompatible.They were advised to put a new sensor.There was no report of adverse heath impact and any self or third-party medical treatment.No contact information was provided to adc; therefore, adc is unable to attempt any follow up activities related to this event.Based on the information provided, there was no report of serious injury associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda 94502-7001 ; 4157205405
• MDR Report Key: 23850923
• Report Number: 2954323-2025-48894
• Device Sequence Number: 9543682
• Product Code: QBJ
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 72077-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female