BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-T PARADIGM

    MDR report key: 3805812 · Received May 6, 2014

    Report

    Report Number
    MW5036023
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 AT APPROXIMATELY 4:30 AM, I WOKE UP WITH HIGH BLOOD SUGAR. I CHECKED MY EQUIPMENT AND FOUND THAT I HAD ANOTHER MEDTRONIC SURE-T 32" CONNECTING HOSE DISCONNECT AT THE PLASTIC TUBE WELD BETWEEN THE TUBING AND THE INFUSION SET SIDE. THIS IS THE THIRD IN THE LAST MONTH, HAVING NEVER HAD THIS HAPPEN IN THE LAST 5 YEARS OF USING THIS PRODUCT. SINCE THIS HAPPENS WITHIN SEVERAL DAYS OF CHANGING THE INFUSION SET, IT IS IMPOSSIBLE TO KNOW THE EXACT PART AND LOT NUMBER SINCE I USE 3 DIFFERENT TYPES OF INFUSION SETS WITH 32" TUBING. THESE ARE: MMT866 LOT 5047583 EXP. 2018-10, MMT-876 LOT 5043427 EXP 2018-09, MMT-886 LOT 5032820 EXP 2018-05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271151 SURE-T PARADIGM SURE-T INFUSION SET LZG MEDTRONIC MMT-876 5043427
    271152 SURE-T PARADIGM SURE-T INFUSION SET LZG MEDTRONIC MMT-886 5032820
    271227 SURE-T PARADIGM SURE-T INFUSION SET FPA MEDTRONIC MMT-866 5047583

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other