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	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Abbott diabetes care (adc) received a medwatch report which reported the following information: a customer reported their ¿iphone was not compatible with the libre 3 reader app.The incompatibility was caused by the ios version on my phone, my phone had a current version of ios, and the libre 3 reader app was only compatible through several earlier ios versions.¿ no third-party treatment or patient consequences were reported.Adc customer service attempted to contact the customer 3 times to gain additional details regarding this event; however, all follow up attempts were unsuccessful.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.Extended investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or additional information is obtained.The device manufacturing date does not apply.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.
Additional Manufacturer Narrative
The customer reported for incompatible ios.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 operating system and app versions, it restricts the ability to identify potential causes of the customer's reported issue.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care (adc) received a medwatch report which reported the following information: a customer reported their ¿iphone was not compatible with the libre 3 reader app.The incompatibility was caused by the ios version on my phone, my phone had a current version of ios, and the libre 3 reader app was only compatible through several earlier ios versions.¿ no third-party treatment or patient consequences were reported.Adc customer service attempted to contact the customer 3 times to gain additional details regarding this event; however, all follow up attempts were unsuccessful.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: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 20800546
• Report Number: 2954323-2024-46790
• Device Sequence Number: 15161738
• Product Code: QLG
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 11/12/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White