BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 17765542 · Received September 18, 2023

    Report

    Report Number
    2954323-2023-41031
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 12, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WERE NO ISSUES WITH THE LIBRELINK APPLICATION THAT WOULD HAVE LED TO THE COMPLAINT. THE USER REPORTED SIGNAL LOSS. SUCCESSFULLY STARTED LIBRE 2 SENSOR AND RECEIVED GLUCOSE READINGS AND ALARM NOTIFICATIONS USING A SIMILAR CONFIGURATION AND UNABLE TO REPRODUCE THE COMPLAINT. THEREFORE, THE ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXTENDED INVESTIGATION IS PENDING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MANUFACTURING DATE DOES NOT APPLY. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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

    A SIGNAL LOSS ISSUE WAS REPORTED WITH THE ADC DEVICE IN USE WITH IPHONE 12 PHONE, OS VERSION 16.6, APP VERSION 2.10.1.7653. CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO RECEIVE GLUCOSE ALARMS. AS A RESULT, CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED LIGHTHEADEDNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF ORAL GLUCOSE BY THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A SIGNAL LOSS ISSUE WAS REPORTED WITH THE ADC DEVICE IN USE WITH IPHONE 12 PHONE WITH IOS VERSION 16.6. CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO RECEIVE GLUCOSE ALARMS. AS A RESULT, CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED LIGHTHEADEDNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF ORAL GLUCOSE BY THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269135 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71892-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention