BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET INFUSION SET

    MDR report key: 6885821 · Received September 22, 2017

    Report

    Report Number
    MW5072288
    Event Type
    Injury
    Date Received
    September 22, 2017
    Report Date
    September 20, 2017
    Manufacturer
    MEDTRONIC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING A MINIMED INSULIN PUMP FOR MANY YEARS. I HAVE NOTICED PROBLEMS WITH HYPOGLYCEMIA AFTER REPLACING MY INFUSION SET MULTIPLE TIMES. IN (B)(6) 2016, I HAD A CAR ACCIDENT AFTER CHANGING INFUSION SETS AND HAVING CHECKED MY BLOOD GLUCOSE SOON AFTER I LEFT FROM WORK TO DRIVE HOME AND MADE IT TO THE SIDE OF THE ROAD NEAR MY HOUSE-INTO A ROAD BARRIER. POLICE REPORT WAS CREATED. I WENT THROUGH ALL THE STEPS TO SECURE MY DRIVERS LICENSE AFTER A MEDICAL EMERGENCY. HOWEVER, MY NEW CAR WAS TOTALED. THIS CREATED A HAZARD FOR ME AS WELL AS OTHERS. LEARNING NOW THAT A RECALL ON MEDTRONIC'S INFUSION SETS HAS TAKEN PLACE WITH A DESCRIPTION OF WHAT I BELIEVE HAPPENED TO ME IN THIS INSTANCE MAKES ME WONDER HOW LONG THE INFUSION SETS HAVE BEEN MALFUNCTIONING. THIS IS MORE THAN NEWER INSULIN REPLACING OLD INSULIN MAKING IT MORE "POTENT" - THESE ARE LOW BLOOD SUGARS WITHOUT EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666084 QUICK SET INFUSION SET QUICK SET INFUSION SET FRN MEDTRONIC MMT 397

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O