BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 17430942 · Received July 31, 2023

    Report

    Report Number
    2954323-2023-32888
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    July 14, 2023
    Report Date
    July 31, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Removal / Correction Number
    QR908720
    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 AND ANDROID, VERSION 2.10.0. IT IS UNKNOWN WHICH PHONE TYPE THE CUSTOMER WAS USING. FOR ANDROID USERS, DURING PERIODS OF SIGNAL LOSS OLD GLUCOSE DATA WOULD APPEAR AS CURRENT DATA, THUS ALLOWING FOR POTENTIAL OF ERRONEOUS GLUCOSE RESULTS. IN ADDITION, THE SIGNAL LOSS ALARM WOULD NOT FUNCTION PROPERLY, EVEN THOUGH IT WOULD APPEAR AS ENABLED. THIS ISSUE WAS ADDRESSED IN THE FIELD BY ADC FA1032-2023. FOR IOS USERS, USERS RECEIVED A WHITE SCREEN IN THE APPLICATION USER INTERFACE (UI). 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. BASED ON THE INVESTIGATION, THIS COMPLAINT IS CONFIRMED. THIS ISSUE WAS ADDRESSED IN THE FIELD BY ADC FA1029-2023 AND RESOLVED ON 17-JUL-2023. BASED ON THE INVESTIGATION, THE COMPLAINT IS CONFIRMED AND NO FURTHER INVESTIGATION ACTIVITIES FOR THIS INDIVIDUAL COMPLAINT ARE REQUIRED. SECTION D4 MODEL # WAS POPULATED AS UNKNOWN AS CUSTOMER DID NOT REPORT WHICH OPERATING SYSTEM WAS IN USE AT THE TIME OF THE EVENT. IT IS KNOWN THAT THIS EVENT IS ASSOCIATED WITH EITHER FREESTYLE LIBRELINK/FREESTYLE LIBRE 2 IOS APPLICATION PART NUMBER 71733-01/71926-01 OR FREESTYLE LIBRELINK/FREESTYLE LIBRE 2 ANDROID APPLICATION PART NUMBER 71732-01/71857-01. 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 UNKNOWN, IN USE WITH UNKNOWN PHONE WITH UNKNOWN OPERATING SYSTEM VERSION. THE CUSTOMER REPORTED "APP DOES NOT EXIST IN THE APP STORE" AND AS A RESULT, THEY EXPERIENCED A LOSS OF CONSCIOUSNESS EACH DAY FOR 3 DAYS. THERE WAS NO REPORT OF TREATMENT. ADC HAS IDENTIFIED AN ISSUE WITH THE RELEASE OF THE FREESTYLE LIBRELINK (FSLL) APP FOR ANDROID AND IOS V2.10.0 ON (B)(6) 2023 IN THE UNITED KINGDOM AND IRELAND. FOR ANDROID USERS, SOME USERS HAVE EXPERIENCED A SITUATION IN WHICH THE APPLICATION UPGRADE WAS UNSUCCESSFUL AND DURING PERIODS OF SIGNAL LOSS, OLD GLUCOSE DATA WOULD APPEAR AS CURRENT DATA, THUS ALLOWING FOR THE POTENTIAL OF ERRONEOUS GLUCOSE RESULTS. IN ADDITION, THE SIGNAL LOSS ALARM WOULD NOT FUNCTION PROPERLY, EVEN THOUGH IT WOULD APPEAR AS ENABLED. THIS ISSUE WAS ADDRESSED IN THE FIELD BY ADC FA1032-2023. THIS ISSUE DOES NOT AFFECT USERS IN THE UNITED STATES. FOR IOS USERS, SOME USERS HAVE EXPERIENCED A SITUATION WHERE THE APPLICATION UPGRADE WAS UNSUCCESSFUL, AND AS A RESULT, THEY RECEIVED A WHITE SCREEN IN THE APPLICATION USER INTERFACE (UI). 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 RELEASE OF UPDATED FSLL IOS APPLICATION MADE AVAILABLE IN THE APPLE APP STORE IN THE UK ON (B)(6) 2023. THIS ISSUE DOES NOT AFFECT USERS IN THE UNITED STATES. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634529 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71892-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other