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

Model Number	71732-01
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is pending at this time.A follow up will be submitted once additional information is obtained.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
A "replace sensor" error message was reported with the abbott diabetes care (adc) device and the customer was unable to obtain glucose readings.As a result, the customer experienced symptoms of hypoglycemia such as seizure, loss of consciousness and was unable to self-treat.The customer was taken to a hospital, where a healthcare professional administered glucose and fluids.Pain relief was provided, and efforts were made to stabilize blood glucose levels.Unspecified injections were also given as part of the treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The product has been requested back for an investigation and the customer agreed to return the device; however, at this time product has not yet been received.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.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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 user reported replace sensor error message.The reported issue was investigated, found no connection between the customer's reported application and the customer's reported issue.The investigation did not identify the app because the reported issue was associated with a sensor related malfunction.This errors were recorded in the receiver¿s event log when the sensor experienced a fault.The application was functioning correctly as it was accurately displaying the error message generated by the sensor.This indicated that the app was operating as intended and was not the source of the issue.No malfunction was identified with the customer's reported application.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor and sensor kit was reviewed and the dhrs showed the libre sensor and sensor kit met specifications prior to release to distribution.If product is returned, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A "replace sensor" error message was reported with the abbott diabetes care (adc) device in use with samsung galaxy s22 sn-(b)(6), os version 15 and app version 2.12.1.11476 and the customer was unable to obtain glucose readings.As a result, the customer experienced symptoms of hypoglycemia such as seizure, loss of consciousness and was unable to self-treat.The customer was taken to a hospital, where a healthcare professional administered glucose and fluids.Pain relief was provided, and efforts were made to stabilize blood glucose levels.Unspecified injections were also given as part of the treatment.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 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda 94502-7001 ; 4157205405
• MDR Report Key: 22822416
• Report Number: 2954323-2025-32469
• Device Sequence Number: 13162374
• 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,Followup
• Report Date (Section B): 08/28/2025

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 Expiration Date: 09/30/2026
• Device Model Number: 71732-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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