BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM 715

    MDR report key: 1842541 · Received September 19, 2010

    Report

    Report Number
    MW5017493
    Event Type
    Injury
    Date Received
    September 19, 2010
    Date of Event
    June 4, 2009
    Report Date
    September 19, 2010
    Manufacturer
    MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS WEARING THE MINIMED PARADIGM 715 PUMP AS ALWAYS WHEN I WENT TO BED THAT NIGHT AND SOMETIME IN THE NIGHT, THE INFUSION LINE TO THE PUMP BROKE WHERE THE LINE COMES OUT OF THE CAP ON IT. I WAS FOUND THE NEXT DAY ON THE FLOOR WITH A 1402 BLOOD SUGAR I WAS ON LIFE SUPPORT FOR 4 DAYS AND HOME IN 11 DAYS. I CALLED MINIMED ON THIS ISSUE, AND THEY SAID IT WILL NEVER HAPPEN AGAIN AND THAT THEY HAD NEVER HEARD OF IT HAPPENING TO ANYONE ELSE. THAT IS FINE BUT I AM CONCERNED THAT IT COULD HAPPEN TO ME AGAIN OR TO ANOTHER PERSON. I HAVE NEVER COME BACK TO WHAT I WAS BEFORE THE COMA. I AM NOW ON COMPLETE DISABILITY AND AM NOT SURE IF THIS COULD HAVE LEAD TO MY DISABILITY. THEIR COMPLETE LACK OF CONCERN SCARED ME! I ALSO WROTE THEM ON THIS ISSUE ONLINE AND NEVER GOT A REPLY FROM THAT LETTER TO THEM. THIS HAPPENED IN (B)(6). I WAS TAKEN TO (B)(6) HOSPITAL THERE. HOSPITALIZED FROM (B)(6) 2009 -(B)(6) 2009. DIAGNOSIS OR REASON FOR USE: TYPE 1 DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM 715 MINIMED INSULIN PUMP INFUSION LINE LZG MINIMED LOT #08

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L