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	01/20/2026
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 reported low glucose alarm issue on the adc application and was investigated.After attempting to identify the customer's reported configurations, the information provided in the complaint was insufficient to conduct a comprehensive investigation.The lack of the correct application version 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.The most probable root causes associated with this failure mode are 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 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
An unexpected application issue was reported with the abbott diabetes care (adc) device in use with samsung galaxy s25 ultra phone with android operating system version 16.The customer was unable to monitor their glucose level because they only received a single low alarm alert through libre linkup caregiver application, but the notifications are being sent to their spouse only.As a result, the customer's spouse contacted 911 after receiving alerts indicating the customer's blood glucose level had fallen below 60 mg/dl while at work.The customer remained under paramedic care for over 40 minutes, during which time no alert notifications were received on their adc device.No clinical symptoms were reported however, customer was unable to self-treat and the provided third-party treatment was unknown.The customer was contacted on three separate occasions to gain additional details regarding this event; however, all attempts were unsuccessful.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: 24377176
• Report Number: 2954323-2026-09632
• Device Sequence Number: 5650464
• Product Code: QLG
• UDI-Device Identifier: 00357599816001
• UDI-Public: 00357599816001
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K213996
• 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
• Report Date (Section B): 02/18/2026

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: 01/20/2026
• Initial Report FDA Received Date: 02/18/2026
• 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: Male