BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE 14 DAY SENSOR KIT

    MDR report key: 15198357 · Received August 9, 2022

    Report

    Report Number
    MW5111403
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 8, 2022
    Manufacturer
    ABBOTT DIABETES CARE, INC.
    Product Code
    PZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPEATEDLY, I HAVE USED THE FREESTYLE LIBRE 14 DAY SENSOR, AND IT HAS FALLEN OFF WITHIN IN DAYS OF PLACING ON MY ARM. SEVERAL TIMES, I WAS JUST TRYING TO SCAN THE SENSOR WITH MY PHONE, AND IT JUST FELL OFF, AND I HAD TO SEEK MEDICAL TREATMENT FOR LOW BLOOD SUGAR. OTHER TIMES, THE SENSOR WILL EXHIBIT ERROR MESSAGES WHEN TRYING TO SCAN THE SENSOR FORCING ME TO HAVE TO REPLACE IT WITH ANOTHER SENSOR. IN MY OPINION, ABBOTT DIABETES CARE, INC. IS AWARE THAT THESE SENSORS ARE FAULTY, AND THAT IS WHY THE ORGANIZATION IS EAGER TO REPLACE THE SENSOR, AND THEN HAVE THE CUSTOMER RETURN THE SENSOR FOR" RESEARCH AND TROUBLESHOOTING." AS A CONSUMER, I AM FRUSTRATED AND TIRED OF SPENDING MONEY ON THESE DEFECTIVE SENSORS, AND MY TIME IN CALLING AND GETTING A REPLACEMENT DAYS LATER. THIS PROCESS PUTS MY LIFE IN JEOPARDY AND CAUSES A FINANCIAL HARDSHIP ON MY FAMILY TO REPLACE THE SENSORS WHILE I WAIT FOR THE COMPANY TO SEND ME A REPLACEMENT. LASTLY, IF ABBOTT DIABETES CARE, INC. IS KNOWINGLY PROVIDING DEFECTIVE SENSORS THEN THIS IS DEVASTATINGLY UNETHICAL, AND IT COULD CAUSE FATAL CIRCUMSTANCES FOR PRODUCT USERS. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711990 FREESTYLE 14 DAY SENSOR KIT SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED PZE ABBOTT DIABETES CARE, INC. 0M000N22RER

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Disability| H| R