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

Model Number	72075-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer experienced missing high glucose alarms with the reported application.Per the compatibility guide, use of the motorola g stylus with an android operating system is incompatible with the reported application software version 3.6.5.11962.This guide is available to the user on the websites where the product is launched.The most probable root causes associated with this failure mode are error codes generated during typical intended operation, software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.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
A complaint was received via chat.A customer reported an incompatible operating system issue when using an abbott diabetes care (adc) device with a motorola g stylus running android version 13.The customer stated that the high glucose alarm did not activate during the night, even though glucose readings were between 450 mg/dl and 500 mg/dl.It is unknown what symptoms the customer experienced; however, they were advised by their healthcare professional to go to the emergency room.Furthermore, the type of treatment provided when the customer self-presented to the emergency room is unknown.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The user reported not receiving alarms.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.This also serves as a correction report.Section h11 (additional mfg narrative) was incorrectly documented in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A complaint was received via chat.A customer reported an incompatible operating system issue when using an abbott diabetes care (adc) device with a motorola g stylus running android version 13.The customer stated that the high glucose alarm did not activate during the night, even though glucose readings were between 450 mg/dl and 500 mg/dl.It is unknown what symptoms the customer experienced; however, they were advised by their healthcare professional to go to the emergency room.Furthermore, the type of treatment provided when the customer self-presented to the emergency room is unknown.There was no report of death or permanent impairment 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, CA 94502-7001 ; 4157205405
• MDR Report Key: 23694405
• Report Number: 2954323-2025-46968
• Device Sequence Number: 10215940
• Product Code: QBJ
• UDI-Device Identifier: 00357599816001
• UDI-Public: 00357599816001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K223435
• 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): 03/04/2026

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: 72075-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown