BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 530

    MDR report key: 4190194 · Received October 15, 2014

    Report

    Report Number
    MW5038686
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    May 1, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONICS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE SENSOR CONSISTENTLY INCORRECTLY DISPLAYS MY BLOOD GLUCOSE LEVELS BY AS MUCH AS 100 - 150 POINTS. I CANNOT RELY ON THIS SENSOR TO CORRECTLY DETERMINE MY BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652660 MINIMED 530 INSULIN PUMP FRN MEDTRONICS 530 G

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR