BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE 2

    MDR report key: 11700551 · Received April 20, 2021

    Report

    Report Number
    MW5100887
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 17, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING THE LIBRE 2 FGM, READINGS ARE OFF BY 50 POINTS HIGHER OR MORE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590709 LIBRE 2 SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR