BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT FREESTYLE LIBRE 3 PLUS

    MDR report key: 24180098 · Received January 26, 2026

    Report

    Report Number
    MW5182792
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 20, 2026
    Report Date
    January 20, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ABBOTT FREESTYLE LIBRE 3 PLUS CGM HAS BEGUN GIVING DANGEROUSLY INACCURATE READINGS. THIS IS A PATTERN THAT HAS BEEN OBSERVED WITH PREVIOUS SENSORS OF THIS SAME MODEL. THE SENSOR STARTS OFF GIVING FAIRLY ACCURATE READINGS THEN IT BECOMES PROGRESSIVELY INACCURATE GIVING READINGS THAT ARE MUCH LOWER THAN THE BLOOD GLUCOSE LEVELS MEASURED BY GLUCOMETER. THIS SENSOR WAS STARTED ABOUT 2315 ON (B)(6) 2026, THE READINGS OVER THE LAST TWO DAYS HAVE BEEN (B)(6) 2026: 0122 SENSOR 110, GLUCOMETER 111; 1037 SENSOR 87, GLUCOMETER 85; 1441 SENSOR 89, GLUCOMETER 89; 2100 SENSOR 110, GLUCOMETER 117; (B)(6) 2026: 0112 SENSOR 162, GLUCOMETER 161; 1012 SENSOR 82, GLUCOMETER 88; 1356 SENSOR 98, GLUCOMETER 123; 2230 SENSOR 91, GLUCOMETER 130. THESE ERRORS ARE FAR BEYOND ABBOTT'S CLAIMED ±15% ACCURACY. IT WOULD BE DANGEROUS IF ANYONE MADE MEDICAL TREATMENT DECISIONS BASED ON THE READINGS PROVIDED BY THE ABBOTT LIBRE 3 PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247026 ABBOTT FREESTYLE LIBRE 3 PLUS INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. T60003805

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male AMLODIPINE BESYLATE.| ASPART.| ATORVASTATIN.| CALCIUM.| CHOLECALCIF.| DORZOLAMIDE/TIMOLOL.| EMPAGLIFLOZIN.| FENOFIBRATE.| GLARGINE-YFGN.| GLIPIZIDE.| INSULIN.| INSULIN.| LEVOTHYROXINE NA (SYNTHROID).| LOSARTAN.| METFORMIN.| MINOCYCLINE HCL.| RIVAROXABAN.