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

Model Number	72075-01
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem (2880)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 customer reported signal loss.The reported issue was investigated and attempted to be replicated.Per the abbott diabetes care compatibility guide for the freestyle libre 3 app (art43193-006), the reported configuration of [android 14] is not compatible with the freestyle libre 3 app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.There were no issues identified with the freestyle libre 3 app during replication that would have led to the reported issue.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 alarm issue was reported with the abbott diabetes care (adc) device in use with a samsung galaxy s23 ultra with android operating system version 14.The customer experienced a signal loss and was delayed to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and reported experiencing loss of consciousness was unable to self-treat however, no third party treatment was reported.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: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18986126
• Report Number: 2954323-2024-10180
• Device Sequence Number: 2894446
• Product Code: QLG
• UDI-Device Identifier: 00357599816001
• UDI-Public: 00357599816001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/27/2024

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: 72075-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown