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

Model Number	71733-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	11/06/2025
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.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink ios application as this report concerns a united kingdom customer.This is same/similar to us freestyle libre 2 ios application, model number 71926-01.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An incompatible application issue was reported with the abbott diabetes care (adc) device in use with iphone 13 with ios operating system and version 18.6.2.As a result, customer was unable to monitor glucose readings due to the device showing "check sensor" and no glucose alarms.The customer experienced loss of consciousness.Later on, the customer woke up and self-treated with "jelly babies".No third-party treatment was provided.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The user reported not receiving alarms.The reported issue was investigated.The reported configuration was not compatible with the customer's reported application.The latest revision of the compatibility guide was 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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An incompatible application issue was reported with the abbott diabetes care (adc) device in use with iphone 13 with ios operating system and version 18.6.2 , app version 2.12.2.8979.As a result, customer was unable to monitor glucose readings due to the device showing "check sensor" and no glucose alarms.The customer experienced loss of consciousness.Later on, the customer woke up and self-treated with "jelly babies".No third-party treatment was provided.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: 23580540
• Report Number: 2954323-2025-45097
• Device Sequence Number: 9222829
• Product Code: PZE
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• 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): 11/20/2025

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: 11/10/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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