BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRE3 SENSOR

    MDR report key: 23923611 · Received December 30, 2025

    Report

    Report Number
    MW5181467
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS STARTING TO FEEL "OFF" A FEW DAYS BEFORE THIS MAJOR DIABETIC KETOACIDOSIS EVEN THAT LEFT ME HOSPITALIZED. ON (B)(6) 2025, I WAS PALE, WEAK, AND STARTED HAVING CHEST PAIN. MY LIBRE3 REPORTED LOW BLOOD SUGAR THE COUPLE OF DAYS PRIOR, WHICH LED ME TO TAKE IN INCREASED DOSES OF CARBOHYDRATES. ON THIS DAY, MY LIBRE3 SHOWED MY BLOOD SUGAR LEVELS TO BE BETWEEN 210-230. 911 WAS CALLED AND WHEN THE PARAMEDICS ARRIVED AND MY BLOOD SUGAR WAS TAKEN, IT SHOWED "HI", WHICH ACCORDING TO THEM WOULD BE ABOVE 500. I WAS FLOWN VIA CAREFLITE TO (B)(6) WHERE MY FIRST BLOOD DRAW SHOWED MY BLOOD SUGAR LEVEL TO BE 1,320. I WAS ADMITTED AND TREATED FOR DKA AND WAS DISCHARGED FINALLY ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878429 LIBRE3 SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization ASPIRIN 81 MG ONCE DAILY.| ATORVASTATIN 10 MG ONCE DAILY.| CYCLOBENZAPRINE 10 MG THREE TIMES DAILY PRN.| FREESTYLE LIBRE 3 SENSOR.| INSULIN 70-30 55 UNITS BID.| INSULIN REGULAR 10 UNITS TID (ALSO CAN BE SLIDING SCALE).| LEVOTHYROXINE 75 MCG ONCE DAILY.| LOSARTAN-HYDROCHLOROTHIAZIDE 50-12.5 MG DAILY.| MELATONIN 10 MG AT NIGHT PRN.| MIRALAX 17 MG ONCE DAILY.| NITROGLYCERIN 0.4 MG PRN CHEST PAIN.| PANTOPRAZOLE 40 MG BID.| VITAMIN D3 50 MCG TABLET ONCE DAILY.