BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINKUP

    MDR report key: 24916410 · Received April 17, 2026

    Report

    Report Number
    2954323-2026-34346
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    PJT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE LIBRELINKUP APP FREQUENTLY FAILS TO RECEIVE GLUCOSE READINGS. 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 AND OS VERSION FOR LIBRELINKUP APP, 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CAREGIVER REPORTED A DATA-SHARING CONNECTIVITY ISSUE WITH THE ABBOTT DIABETES CARE (ADC) FREESTYLE LIBRELINKUP APP IN USE WITH AN UNKNOWN DEVICE, UNKNOWN OPERATING SYSTEM, AND UNKNOWN APPLICATION VERSION. ACCORDING TO THE CAREGIVER, THE APP FREQUENTLY FAILED TO RECEIVE GLUCOSE READINGS. WHEN READINGS WERE DISPLAYED, THEY APPEARED ONLY BRIEFLY AND WITH A DELAY COMPARED TO THE EXPECTED TIMEFRAME. AS A RESULT, THE CUSTOMER WAS ASYMPTOMATIC AND RECEIVED CAREGIVER-ADMINISTERED TREATMENT CONSISTING OF TWO GLUCOSE SACHETS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969335 FREESTYLE LIBRELINKUP CONTINUOUS GLUCOSE MONITORING RETROSPECTIVE DATA ANALYSIS SOFTWARE PJT ABBOTT DIABETES CARE LTD 72154-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention