BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 16383240 · Received February 15, 2023

    Report

    Report Number
    2954323-2023-06959
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    January 9, 2023
    Report Date
    February 15, 2023
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE READER WERE REVIEWED AND THE DHRS SHOWED THE LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. N/A WAS SELECTED FOR PMA/510(K) AS CUSTOMER IS USING FS LIBRE 3 SENSOR WITH FS LIBRE READER. FS LIBRE 3 SENSOR WITH READER IS NOT APPROVED FOR MARKET IN US, HOWEVER LIBRE 3 IS SAME/SIMILAR TO LIBRE 2 WHICH IS CURRENTLY ON MARKET IN THE US. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72111-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71953-01.  ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE ADC DEVICE WOULD NOT POWER ON WITH BUTTON PRESS AND TEST STRIP INSERTION. DUE TO THIS, THEY WERE UNABLE TO MONITOR GLUCOSE AND EXPERIENCED DIZZINESS, A SEIZURE, AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER'S BLOOD SUGAR WAS MEASURED (RESULT UNSPECIFIED) AND THE CUSTOMER WAS TREATED WITH INSULIN INJECTION (DOSE/TYPE UNKNOWN) BY A HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556633 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 71953-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention