BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3 PLUS

    MDR report key: 22805545 · Received August 14, 2025

    Report

    Report Number
    MW5174536
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY FREESTYLE LIBRE 3 HAS ALERTED ME ON SEVERAL OCCASIONS THAT MY BLOOD SUGAR WAS CRITICALLY LOW (56 MG/DL). I HAVE GOTTEN UP AND REACTED BY IMMEDIATELY EATING/DRINKING ITEMS TO RAISE MY BLOOD SUGAR, WHICH RESULTS IN A SPIKE IN BLOOD SUGAR BECAUSE MY GLUCOSE WAS REALLY 102 MG/DL. I NOW HAVE TO DOUBLE CHECK IT WITH MY OLD METER VIA FINGER PRICK AND SEVERAL TIMES IT IS READING LOW. I HAVE BEEN A DIABETIC FOR OVER 20 YEARS AND HAVE MANAGED IT WELL. THIS SENSOR WAS SUPPOSED TO ELIMINATE FINGER PRICKING, BUT NOW I CAN'T TRUST THE DEVICE. I HAD A BATCH OF SENSORS DO THE SAME THING IN (B)(6). THIS IS A NEW BATCH: LOT T60003079; SN (B)(6) (2025-12-31 EXPIRATION). I DID NOT REPORT THE PREVIOUS TWO TIMES. I TAKE GREAT CARE TO PUT THE SENSOR ON AND I'VE FOLLOWED ABBOTT'S DIRECTIONS TO THE LETTER. PATIENT CODE: 1905. DEVICE CODE: 2460. REFERENCE REPORTS MW5174535 AND MW5174537.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226241 FREESTYLE LIBRE 3 PLUS INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female MAGNESIUM.| MONJOURO.| PLAVIX.| TRELEGY.