BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT FREESTYLE LITE STRIPS

    MDR report key: 7780302 · Received August 13, 2018

    Report

    Report Number
    MW5079112
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 11, 2018
    Manufacturer
    ABBOTT DIABETES CARE, INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY GLUCOSE BLOOD MONITORING STRIPS DO NOT WORK. THEY DO NOT ABSORB THE BLOOD. I HAVE BEEN TESTING THEM FOR OVER A WEEK, AND THEY STILL DO NOT WORK. PRODUCT: ABBOTT FREESTYLE LITE STRIPS LIST NO: 71026-70, NDC: (B)(4), LOT: 1049963 2020-04-30, CODE:16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619716 ABBOTT FREESTYLE LITE STRIPS GLUCOSE DEHYDROGENASE GLUCOSE LFR ABBOTT DIABETES CARE, INC. FREE STYLE LITE 1049963

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other