BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 24867643 · Received April 13, 2026

    Report

    Report Number
    2954323-2026-28838
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. SECTION D. SUSPECTED MEDICAL DEVICE AND G4 - PMA/510(K)# HAS BEEN POPULATED FOR THE FREESTYLE LIBRELINK IOS APPLICATION AS THIS REPORT CONCERNS A BRAZIL CUSTOMER. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRE 2 IOS APPLICATION, MODEL NUMBER 71926-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING GLUCOSE INJECTION TO BE PROVIDED BY A HEALTHCARE PROFESSIONAL FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928573 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71733-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention