BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 25271455 · Received May 25, 2026

    Report

    Report Number
    2954323-2026-92236
    Event Type
    Malfunction
    Date Received
    May 25, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 25, 2026
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QBJ
    UDI-DI
    00357599818005
    PMA / PMN Number
    K223435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. 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

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 156, 119, 251, 156 MG/DL COMPARED TO READINGS OF 220, 251, 317, 243 MG/DL RESPECTIVELY OBTAINED ON A METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS 5 DAYS. 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
    615584 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QBJ ABBOTT DIABETES CARE LTD 72081-01 00357599818005

    Patients

    Seq Age Sex Outcome Treatment
    1