BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2 BLOOD GLUCOSE MONITOR

    MDR report key: 15380077 · Received September 7, 2022

    Report

    Report Number
    MW5111916
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    September 4, 2022
    Report Date
    September 29, 2022
    Manufacturer
    ABBOTT DIABETES CARE, INC.
    Product Code
    QLG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HI, I HOPE YOU CAN HELP ME. I'M ON MEDICARE AND DIABETIC AND HAVE A FREESTYLE LIBRE 2 GLUCOSE MONITOR. THIS THING IS JUNK AND I'VE CONTACTED ABBOTT NUMEROUS TIMES. I'M ON THE THIRD ONE AS OF THIS MORNING. I WANT TO GET RID OF IT AND SWITCH TO A DEXCOM G6 BUT I HEAR MEDICARE WILL ONLY PAY FOR A NEW ONE EVERY 5 YEARS. I JUST STARTED THE THIRD LIBRE 2 THIS MORNING AND I GOT A LOW GLUCOSE ALARM. THE METER SAID I WAS AT 67. I KNEW THIS COULD NOT BE TRUE SO I CHECKED WITH A FINGER PRICK AND MY METER SAID 255. THIS IS INSANE!!! THE LAST 2 LIBRE 2'S WERE CONSTANTLY SPITTING OUT ERROR MESSAGES TO THE POINT THEY WERE RUNNING THEIR OWN BATTERY DOWN FROM ALL THE ERRORS. THIS NEW ONE IS NOT READING MY BLOOD GLUCOSE CORRECTLY. ABBOTT SEEMS UNABLE TO GET ME ONE THAT WORKS CORRECTLY AND I DON'T WANT TO MESS WITH THIS THING ANYMORE. CAN MEDICARE GO AFTER THEM FOR THIS JUNK AND HOW CAN I GET A DEXCOM G6 ? THANK YOU. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW111916 ON 09/29/2022 FOR PROCODE QLG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077629 FREESTYLE LIBRE 2 BLOOD GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE, INC.
    2077630 FREESTYLE LIBRE 2 BLOOD GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE, INC.
    2077631 FREESTYLE LIBRE 2 BLOOD GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE, INC.
    2645922 FREESTYLE LIBRE 2 BLOOD GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE, INC.
    2645923 FREESTYLE LIBRE 2 BLOOD GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE, INC.
    2645924 FREESTYLE LIBRE 2 BLOOD GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Life Threatening INSULIN