BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREE STYLE LIBRE 14 DAY GLUCOSE INVASIVE

    MDR report key: 8739742 · Received June 26, 2019

    Report

    Report Number
    MW5087653
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    April 17, 2019
    Report Date
    June 6, 2019
    Manufacturer
    ABBOTT DIABETES CARE, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FIRST, I WANT TO SAY I LIKE FREESTYLE LIBRE 14 DAY, A GREAT PRODUCT. I CALLED ABBOTT LABS AS I WAS CONCERNED ABOUT MY ADHESIVE ALLERGY. I CALLED TWICE. THE FIRST TIME ((B)(6)) TOO BUSY - KEPT ON LONG HOLD. THE SECOND CALL ((B)(6)) SOMEONE SUGGESTED USING SKIN TAC "A LIQUID HYPOALLERGENIC LATEX FREE SKIN BARRIER." (NEVER HAD CHANCE TO USE IT.) ON (B)(6) 2019, WHEN IT WAS TIME TO REMOVE THE ROUND SENSOR FROM MY RIGHT ARM, I HAD A RED RING ALONG WITH A BRUISE WHERE THE POINT ENTERED MY SKIN (NO MARKS ON LEFT ARM). ON (B)(6) 2019 DR (B)(6) SAW MY SKIN'S REACTION. HE IMMEDIATELY DISCONTINUED THE PRODUCT AND ORDERED LABS - VIT D DEFICIENCY AND AN A1C RESULTS - LOW VIT D, A1C - OK. HE ORDERED 1000 VIT D QD. I HAVE SORE BICEPS MOSTLY RIGHT ARM. NO SIGNS OF INFECTION. HARD TO LIFT HEAVIER ITEMS. I WOULD CONTINUE LOSING THIS PRODUCT IF ADHESIVE WASN'T USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531601 FREE STYLE LIBRE 14 DAY GLUCOSE INVASIVE SENSOR GLUCOSE INVASIVE MDS ABBOTT DIABETES CARE, INC. 0320530

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other