BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 23580540 · Received November 18, 2025

    Report

    Report Number
    2954323-2025-45097
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    UDI-DI
    00357599000059
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494533 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71733-01 00357599000059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other