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	Loss of consciousness (2418)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An incompatible application issue was reported with the abbott diabetes care (adc) device in use with iphone 12 with ios operating system and version 18.6.2.As a result, customer was unable to monitor glucose readings due to the device showing signal loss and no glucose alarms.The customer experienced loss of consciousness in the middle of the street and hit their face with something and passersby called ambulance for them.The customer received unspecified third-party treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Investigation is pending at this time.A follow up will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 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
An incompatible application issue was reported with the abbott diabetes care (adc) device in use with iphone 12 with ios operating system version 18.6.2 with software version 3.6.5.12633.As a result, customer was unable to monitor glucose readings due to the device showing signal loss and no glucose alarms.The customer experienced loss of consciousness in the middle of the street and hit their face with something and passersby called ambulance for them.The customer received unspecified third-party treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The user reported signal loss and no alarms due to incompatible application issue.The reported issue was investigated.The reported configuration was not compatible with the customer's reported application.The compatibility guide was available to the customer on the product's website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.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: patricia reis castro ; 1360 south loop road; alameda 94502-7001 ; 4157205405
• MDR Report Key: 23454678
• Report Number: 2954323-2025-43256
• Device Sequence Number: 13013874
• Product Code: QLG
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 11/05/2025

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: 10/24/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown