MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number	71732-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An extended investigation was conducted in response to the reported complaint of signal loss, when using the freestyle librelink application.Connected keithley to simvivo test fixture.Inserted known good sensor into test fixture.Downloaded app and complete initial app setup steps.Scanned known good sensor to app.Observed 60-minute warm-up.Enabled ¿signal loss alarm¿ feature in the app.Placed phone device in faraday bag to interrupt signal to sensor.Signal loss alarm observed after 20 minutes.Removed phone from bag and confirmed sensor reconnected within five minutes.App connected to sensor and functioned as intended.Replication of the issue was attempted using a similar configuration of samsung galaxy s24 (android 16, 2.13.1.11596).Despite a comprehensive investigation, the reported issue could not be replicated, and the system functioned as intended under the tested conditions.Potential causes based on the customer¿s reported application and device history were also examined, but no issues were identified during replication that could have led to the reported issue.Therefore, the issue is not confirmed.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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An unspecified issue was reported with the abbott diabetes care (adc) device in use with a samsung phone 721b and android operating system version 2.13.1.11596.The customer reported that due to signal loss their glucose levels and they were not alerted to the changes in these levels.As a result, the customer lost consciousness.After an unspecified amount of time, the customer regained consciousness and self-treated by consuming food.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• Common Device Name: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 25712207
• Report Number: 2954323-2026-151201
• Device Sequence Number: 21493641
• Product Code: PZE
• UDI-Device Identifier: 00357599000042
• UDI-Public: 00357599000042
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P160030
• 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): 07/04/2026

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: 71732-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 07/05/2026
• 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: Other
• Patient Sex: Unknown