BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE CGM

    MDR report key: 9341431 · Received November 18, 2019

    Report

    Report Number
    MW5091157
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ABBOTT DIABETES CARE, INC.
    Product Code
    PHV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FREESTYLE LIBRE CGM DEVICE SHOWED LOW BLOOD GLUCOSE READINGS OF 60; I GOT WORRIED AND DRANK SOME OJ; THE READINGS STILL SHOWED LOW; I DRANK MORE OJ, THEN FELT VERY FAINT. MY HUSBAND THEN TESTED MY BLOOD SUGAR WITH STRIPS AND THAT SHOWED 280; BUT MY LIBRE METER STILL SHOWED 60. THIS PRODUCT IS UNRELIABLE AND DANGEROUS. SCARY EXPERIENCE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131022 FREESTYLE LIBRE CGM CONTINUOUS, GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE PHV ABBOTT DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other