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

Model Number	71733-01
Medical Device Problem Codes	Unable to Obtain Readings (1516); Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	11/14/2025
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.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink ios application as this report concerns a netherlands 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 os or incompatible device" issue was reported with the abbott diabetes care (adc) in use with an iphone 15, ios operating system version 18.6.2, and application version 2.12.2.8979.The customer reported that their app had a "signal loss" with the sensor therefore, the customer was not alerted of changes in their glucose levels.The customer experienced loss of consciousness and was unable to self-treat.The customer's blood glucose was measured and they were given glucose infusion by a healthcare professional for a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The user reported missing alarms and notifications.The reported issue was investigated.The reported configuration was not compatible with the customer's reported application.The compatibility guide is available to the customer on the product's website.As the compatibility guide was 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 os or incompatible device" issue was reported with the abbott diabetes care (adc) in use with an iphone 15, ios operating system version 18.6.2, and application version 2.12.2.8979.The customer reported that their app had a "signal loss" with the sensor therefore, the customer was not alerted of changes in their glucose levels.The customer experienced loss of consciousness and was unable to self-treat.The customer's blood glucose was measured and they were given glucose infusion by a healthcare professional for a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.

• Brand Name: 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: 23665737
• Report Number: 2954323-2025-46377
• Device Sequence Number: 12993649
• Product Code: PZE
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 12/31/2025

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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• 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