BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 25066891 · Received May 4, 2026

    Report

    Report Number
    2954323-2026-60398
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    June 6, 2025
    Report Date
    May 4, 2026
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QBJ
    UDI-DI
    00357599818005
    PMA / PMN Number
    K223435
    Removal / Correction Number
    2954323-11/22/25-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADC INVESTIGATED THIS ISSUE AND DETERMINED THAT THE SENSOR ASSOCIATED WITH THIS COMPLAINT MAY NOT MEET PRODUCT DESIGN SPECIFICATIONS AND MAY PRODUCE LOW GLUCOSE READINGS WHICH ARE NOT CLINICALLY ACCEPTABLE. THIS PRODUCT HAS BEEN DETERMINED TO BE WITHIN THE SCOPE OF THE INVESTIGATION AHTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/B5.JSF#ND ACTIONS CONDUCTED UNDER ADC FIELD ACTION FA1002-2025. NO FURTHER INVESTIGATION ACTIONS ARE REQUIRED AS THIS ISSUE IS CONFIRMED TO BE IN THE SCOPE OF ADC FA1002-2025. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING LOW GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE (ADC) DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY ADC FIELD ACTION FA1002-2025. IMPACTED PRODUCT WAS DISTRIBUTED TO ANDORRA, AUSTRIA, BELGIUM, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, SAN MARINO, SPAIN, SWEDEN, SWITZERLAND, UK, US, AND QATAR. ADC FIELD ACTION FA1002-2025 WAS ISSUED ONLY TO IMPACTED COUNTRIES. THIS REPORT IS BEING SUBMITTED AS PART OF RETROSPECTIVE REPORTING RELATED TO FA1002-2025. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629427 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE LTD 72081-01 T60003054 00357599818005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown