BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 20125474 · Received September 3, 2024

    Report

    Report Number
    2954323-2024-33945
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    UDI-DI
    00357599000042
    PMA / PMN Number
    K210943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS PENDING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MANUFACTURING DATE DOES NOT APPLY. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE USER REPORTED SIGNAL LOSS. THE REPORTED ISSUE WAS INVESTIGATED AND ATTEMPTED TO REPLICATE. THE REPORTED CONFIGURATION WAS NOT COMPATIBLE WITH THE CUSTOMER REPORTED APP. THE LATEST REVISION OF THE COMPATIBILITY GUIDE WAS AVAILABLE TO THE CUSTOMER ON THE ABBOTT DIABETES CARE WEBSITE. AS THE COMPATIBILITY GUIDE WAS 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.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED VIA EMAIL. AN UNSPECIFIED ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG PHONE WITH ANDROID OPERATING SYSTEM VERSION SM-A54B6. THE CUSTOMER WAS UNABLE TO ACCESS THEIR FREESTYLE LIBRELINK. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE WITH SENSOR READINGS AND EXPERIENCED CONVULSIONS AND WAS ABLE TO SELF-TREAT WITH "1WW". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED VIA EMAIL. AN UNSPECIFIED ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG PHONE WITH ANDROID OPERATING SYSTEM VERSION SM-A54B6. THE CUSTOMER WAS UNABLE TO ACCESS THEIR FREESTYLE LIBRELINK. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE WITH SENSOR READINGS AND EXPERIENCED CONVULSIONS AND WAS ABLE TO SELF-TREAT WITH "1WW". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717611 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71732-01 00357599000042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other