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

Model Number	71733-01
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	09/18/2025
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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink ios application as this report concerns an ireland customer.This is same/similar to us freestyle libre 2 ios application, model number 71926-01.The operating system is unknown so product information provided is for ios.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An email complaint was received in which an alarm issue was reported with the abbott diabetes care (adc) device in use with unknown phone, operating system and version.A healthcare professional reported that the low glucose alarms did not sound and the customer was not alerted of changes in glucose level.The customer had hypoglycemia for 4 hours and loss of consciousness.An ambulance was called, but no further information was provided.The adc customer service made three attempts to gather additional information but was unsuccessful.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 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.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.A valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The available tracking and trending reports were conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.The user reported complaint that missing low glucose alarms.The reported issue 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 device model, os version and app version, restricts the ability to identify potential causes of the customer's reported issue.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
An email complaint was received in which an alarm issue was reported with the abbott diabetes care (adc) device in use with unknown phone, operating system and app version.A healthcare professional reported that the low glucose alarms did not sound and the customer was not alerted of changes in glucose level.The customer had hypoglycemia for 4 hours and loss of consciousness.An ambulance was called, but no further information was provided.The adc customer service made three attempts to gather additional information but was unsuccessful.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: 23156382
• Report Number: 2954323-2025-38614
• Device Sequence Number: 17437892
• Product Code: PZE
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 10/16/2025

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 Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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