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	10/01/2024
Type of Reportable Event	Serious Injury
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 operating system is unknown so product information provided is for ios.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.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.
Event or Problem Description
Abbott diabetes care (adc) received a medwatch report which reported the following information: an application issue was reported with the adc device in use with an unknown phone and unknown operating system.A customer reported their ¿libre 3 app stopped working¿ and they ¿had to log in to the app and it started working again but lost all previous information¿.Customer further reported they did not have any low or high blood sugar or any alarms.No patient consequences were reported.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.
Event or Problem Description
Abbott diabetes care (adc) received a medwatch report which reported the following information: an application issue was reported with the adc device in use with an unknown phone, unknown operating system and unknown app version.A customer reported their ¿libre 3 app stopped working¿ and they ¿had to log in to the app and it started working again but lost all previous information¿.Customer further reported they did not have any low or high blood sugar or any alarms.No patient consequences were reported.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
An investigation was performed for the reported complaint.The customer reported application issues.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 operating system, it restricts the ability to identify potential causes of the customer's reported issue.Therefore, the issue is not confirmed due to the inadequate information provided.All pertinent information available to abbott diabetes care has been submitted.

• 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: 20509008
• Report Number: 2954323-2024-41822
• Device Sequence Number: 9087999
• Product Code: QLG
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/05/2024

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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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 Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White