BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 17455487 · Received August 3, 2023

    Report

    Report Number
    2954323-2023-33468
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    July 15, 2023
    Report Date
    August 3, 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, 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 UNKNOWN, IN USE WITH IPHONE 11 PRO WITH IOS OPERATING SYSTEM VERSION 16.5.1. THE CUSTOMER INDICATED THAT ON 13 JUL 2023, UPON OPENING THE APPLICATION, THEY OBSERVED A BLANK SCREEN AND WAS THEREFORE UNABLE TO MONITOR GLUCOSE. THE CUSTOMER FELT THEIR BLOOD GLUCOSE WAS HIGH, INDICATING THEY EXPERIENCED CHEST PAIN. THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE THEY WERE DIAGNOSED WITH DIABETIC KETOACIDOSIS AND REPORTED TO HAVE EXPERIENCED CARDIAC ARREST. THE CUSTOMER WAS TREATED WITH INFUSION INCLUDING INSULIN, POTASSIUM, SALINE, AND ELECTROLYTES. THE DISEASE OF DIABETES ITSELF IS ASSOCIATED WITH AN INCREASED RISK OF MYOCARDIAL INFARCTION, AND THIS RISK IS GREATER WITH PROLONGED UNCONTROLLED DIABETES. ADDITIONALLY, IT WAS INDICATED BY CUSTOMER THAT THEY HAD ALSO PREVIOUSLY UNDERGONE BYPASS SURGERY. THERE IS NO DIRECT CORRELATION OR INDICATION THAT THE REPORTED DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED MYOCARDIAL INFARCTION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467027 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71892-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H