BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM

    MDR report key: 19529663 · Received June 12, 2024

    Report

    Report Number
    MW5156237
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 17, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QLG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 6/17/2024 FOR REPORT MW5156237 TO UPDATE THE PROCODE TO QLG.

    Description of Event or Problem · 0

    I NEED TO USE A FREESTYLE LIBRE 14 DAY ATTACHED GLUCOSE MONITOR. I HAVE A SEVERE COLOPHONY ALLERGY AND NEED TO KNOW IF THE DEVICE ADHESIVE CONTAINS COLOPHONY. THE PRODUCT IS NOT LABELED WITH ADHESIVE INGREDIENTS, WHICH I BELIEVE IS IN VIOLATION OF FDA REGULATIONS. AFTER CONTACTING THE MANUFACTURER (ABBOTT) AT TWO DIFFERENT NUMBERS, NOBODY COULD TELL ME INGREDIENTS OR WHETHER THE ADHESIVE CONTAINS COLOPHONY OR ITS CHEMICAL DERIVATIVES. TODAY AN ABBOTT REPRESENTATIVE RETURNED MY PHONE CALL AND REFUSED TO GIVE THE INFORMATION. HE STATED THAT A PHYSICIAN MUST SUBMIT A FORMAL MEDICAL INQUIRY BEFORE THEY WILL REVEAL THE INGREDIENTS OF THE DEVICE ADHESIVE. I BELIEVE THIS IS A VIOLATION OF THE FDA LABELING REQUIREMENTS. IF IT IS NOT, IT SHOULD BE. THE NIH HAS AMPLE EVIDENCE THAT ADHESIVE INGREDIENTS CAN CAUSE SEVERE ALLERGIC REACTION AND IT IS A HEALTH AND SAFETY ISSUE. IF IT DOES NOT ALREADY, THE FDA SHOULD REQUIRE LABELING OF INGREDIENTS ON ALL MEDICAL DEVICES USING ADHESIVES, FROM BANDAIDS TO GLUCOSE MONITORING AND OTHER DEVICES ATTACHED WITH ADHESIVES. THERE IS ABSOLUTELY NO WAY FOR CONSUMERS WITH ALLERGIES TO KNOW IF THESE PRODUCTS ARE SAFE. REFER TO ADD'L DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613535 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE INC. 240222Q
    372608 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE INC. 240222Q

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female