BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINKUP

    MDR report key: 23646770 · Received November 25, 2025

    Report

    Report Number
    2954323-2025-46088
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 12, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    PJT
    UDI-DI
    00357599824006
    PMA / PMN Number
    VERIFY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED DATA SHARING NO LONGER FUNCTIONS AFTER UPDATE. 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 THE DEVICE AND APP VERSION RESTRICTS THE ABILITY TO IDENTIFY POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED ISSUE. THEREFORE, THE REPORTED ISSUE IS NOT CONFIRMED DUE TO THE INADEQUATE INFORMATION PROVIDED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A COMPLAINT VIA EMAIL WAS RECEIVED. AN APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN UNKNOWN PHONE WITH AN IOS OPERATING SYSTEM VERSION. THE CUSTOMER INDICATED THAT THE LIBRELINKUP APPLICATION SEEMS TO NOT BE WORKING AT ALL ON IOS. IT APPEARS THAT THIS ISSUE STARTED RIGHT AFTER UPGRADING THE PHONE AND WATCH TO VERSION 26.1. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE USING SENSOR READINGS AND EXPERIENCED A LOSS OF CONSCIOUSNESS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811589 FREESTYLE LIBRELINKUP CONTINUOUSE GLUCOSE MONITORING RETROSPECTIVE DATA ANALYSIS SOFTWARE PJT ABBOTT DIABETES CARE LTD 72154-01 00357599824006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention