BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE-T PARADIGM

    MDR report key: 3775729 · Received April 22, 2014

    Report

    Report Number
    MW5035790
    Event Type
    Injury
    Date Received
    April 22, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXTREME BLOOD GLUCOSE LEVELS DUE TO TWO SEPARATE ISSUES WITH LEAKS OR BREAKS IN TUBING AT THE INFUSION SET CONNECTION. INCREASED INSULIN AND CHANGING INFUSION SET HAD NO EFFECT. PROACTIVE PT EFFORT STOPPED GLUCOSE LEVELS JUST SHY OF 500 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244616 SURE-T PARADIGM SURE-T PARADIGM LZG MEDTRONIC SURE-T PARADIGM
    244617 MMT-INFUSION SET MMT-INFUSION SET FPA MEDTRONIC MMT-8X6 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening