BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 17431180 · Received July 31, 2023

    Report

    Report Number
    2954323-2023-32902
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    July 14, 2023
    Report Date
    July 31, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVESTIGATED. ADC HAS IDENTIFIED A SOFTWARE DEFECT FOR THE FREESTYLE LIBRELINK APPLICATION FOR IOS, VERSION 2.10.0, IN WHICH THE APPLICATION UPGRADE WAS UNSUCCESSFUL. THIS RESULTED IN A PERIOD WHERE USERS MAY NOT HAVE RECEIVED GLUCOSE RESULTS, OR MAY NOT HAVE BEEN ALERTED TO LOW OR HIGH GLUCOSE ALARMS. BASED ON THE INVESTIGATION, THE COMPLAINT IS CONFIRMED AND NO FURTHER INVESTIGATION ACTIVITIES FOR THIS INDIVIDUAL COMPLAINT ARE REQUIRED. THIS ISSUE WAS ADDRESSED IN THE FIELD BY ADC (B)(6). THE DEVICE MODEL NUMBER POPULATED IN SECTION D4 IS FOR THE FREESTYLE LIBRELINK IOS APPLICATION, ON MARKET IN THE UK. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRELINK/FREESTYLE LIBRE 2 IOS APPLICATION PART NUMBER 71733-01/71926-01. THE DEVICE MANUFACTURER DATE FOR THE REPORTED SERIAL NUMBER IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THIS SERVES AS A CORRECTION REPORT. SECTION H6 (ADVERSE EVENT PROBLEM) WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS REPORT. CORRECTION HAS BEEN MADE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVESTIGATED. ADC HAS IDENTIFIED A SOFTWARE DEFECT FOR THE FREESTYLE LIBRELINK APPLICATION FOR IOS, VERSION 2.10.0, IN WHICH THE APPLICATION UPGRADE WAS UNSUCCESSFUL. THIS RESULTED IN A PERIOD WHERE USERS MAY NOT HAVE RECEIVED GLUCOSE RESULTS, OR MAY NOT HAVE BEEN ALERTED TO LOW OR HIGH GLUCOSE ALARMS. BASED ON THE INVESTIGATION, THE COMPLAINT IS CONFIRMED AND NO FURTHER INVESTIGATION ACTIVITIES FOR THIS INDIVIDUAL COMPLAINT ARE REQUIRED. THIS ISSUE WAS ADDRESSED IN THE FIELD BY ADC FA1029-2023. THE DEVICE MODEL NUMBER POPULATED IN SECTION D4 IS FOR THE FREESTYLE LIBRELINK IOS APPLICATION, ON MARKET IN THE UK. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRELINK/FREESTYLE LIBRE 2 IOS APPLICATION PART NUMBER 71733-01/71926-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN ISSUE WAS REPORTED WITH THE ADC APPLICATION VERSION 2.10.0, IN USE WITH IPHONE 13 WITH IOS OPERATING SYSTEM VERSION 16.5.1. A CUSTOMER REPORTED THAT THEIR APPLICATION WAS DOWN AND IT WAS INDICATED THAT THE CUSTOMER RECEIVED TREATMENT. ADC HAS IDENTIFIED THAT FOLLOWING THE RELEASE OF THE FREESTYLE LIBRELINK (FSLL) APPLICATION FOR IOS, V2.10.0, ON (B)(6)2023 (11AM) IN THE UNITED KINGDOM (UK), SOME USERS HAVE EXPERIENCED A SITUATION WHERE THE APPLICATION UPGRADE IS UNSUCCESSFUL, AND AS A RESULT, THEY RECEIVE A WHITE SCREEN IN THE APPLICATION USER INTERFACE (UI). THIS ISSUE DOES NOT AFFECT USERS IN THE UNITED STATES. THIS WILL RESULT IN A PERIOD WHERE GLUCOSE READINGS AND ALARMS WILL NOT BE RECEIVED, AND HISTORICAL GLUCOSE READINGS WILL NOT BE ACCESSIBLE, AS THE PREVIOUS FSLL APPLICATION, V2.8.1, WAS NO LONGER AVAILABLE TO USERS ON THE APPLE APP STORE. THIS ISSUE WAS ADDRESSED IN THE FIELD BY ADC (B)(6) AND WAS RESOLVED IN THE FIELD BY THE RELEASE OF UPDATED FSLL IOS APPLICATION, MADE AVAILABLE IN THE APPLE APP STORE IN THE UK ON (B)(6)2023. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN ISSUE WAS REPORTED WITH THE ADC APPLICATION VERSION 2.10.0, IN USE WITH IPHONE 13 WITH IOS OPERATING SYSTEM VERSION 16.5.1. A CUSTOMER REPORTED THAT THEIR APPLICATION WAS DOWN AND IT WAS INDICATED THAT THE CUSTOMER RECEIVED TREATMENT. ADC HAS IDENTIFIED THAT FOLLOWING THE RELEASE OF THE FREESTYLE LIBRELINK (FSLL) APPLICATION FOR IOS, V2.10.0, ON 12-JUL-2023 (11AM) IN THE UNITED KINGDOM (UK), SOME USERS HAVE EXPERIENCED A SITUATION WHERE THE APPLICATION UPGRADE IS UNSUCCESSFUL, AND AS A RESULT, THEY RECEIVE A WHITE SCREEN IN THE APPLICATION USER INTERFACE (UI). THIS ISSUE DOES NOT AFFECT USERS IN THE UNITED STATES. THIS WILL RESULT IN A PERIOD WHERE GLUCOSE READINGS AND ALARMS WILL NOT BE RECEIVED, AND HISTORICAL GLUCOSE READINGS WILL NOT BE ACCESSIBLE, AS THE PREVIOUS FSLL APPLICATION, V2.8.1, WAS NO LONGER AVAILABLE TO USERS ON THE APPLE APP STORE. THIS ISSUE WAS ADDRESSED IN THE FIELD BY ADC FA1029-2023 AND WAS RESOLVED IN THE FIELD BY THE RELEASE OF UPDATED FSLL IOS APPLICATION, MADE AVAILABLE IN THE APPLE APP STORE IN THE UK ON 17-JUL-2023. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634535 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71892-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention