BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3 PLUS

    MDR report key: 24737743 · Received March 30, 2026

    Report

    Report Number
    2954323-2026-19161
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 15, 2026
    Report Date
    March 30, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QBJ
    UDI-DI
    05021791007042
    PMA / PMN Number
    K223435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND THE CUSTOMER AGREED TO RETURN THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED A SKIN INFECTION AT THE ADC DEVICE INSERTION SITE. THE CUSTOMER WENT TO A PHARMACY AT AN EMERGENCY MEDICAL SERVICE WHERE THEY HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO PRESCRIBED RIVANOL AND MOXI CLAV 875/125 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
    792069 FREESTYLE LIBRE 3 PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE INC 78768-01 05021791007042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention