BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN PUMP PARADIGM 551

    MDR report key: 3905787 · Received June 25, 2014

    Report

    Report Number
    MW5036904
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING THE MEDTRONIC PARADIGM 551, MINIMED 530G FOR ABOUT A YEAR, AND THE ENLITE SENSORS FOR ABOUT 2 MONTHS. HOWEVER, ABOUT ONE MONTH AGO, ON (B)(6), I TRIED TO UPLOAD MY ENLITE GLUCOSE DATA TO THE MEDTRONIC SYSTEM USING THE LATEST (B)(6) OPERATING SOFTWARE - ONLY TO BE TOLD THAT THE NEW SOFTWARE IS NOT COMPATIBLE WITH (B)(6). "THEY'RE WORKING ON IT". SINCE THEN, I HAVE CALLED AND BEEN TOLD THE SAME THING. TWO WEEKS AGO, I CALLED AND WAS TOLD THAT IT IS AN FDA PROBLEM. THEY WERE WAITING FOR THE FDA APPROVAL. OF COURSE, NOT KNOWING THE DETAILS, THIS SOUNDS STRANGE TO ME. I HAVE NOT USED THE GLUCOSE SENSORS SINCE (B)(6). ALL I KNOW IS THAT I HAVE INVESTED A GREAT DEAL OF TIME AND EFFORT TO INCORPORATE THESE PRODUCTS INTO MY LIFE, NOT TO MENTION THE MONEY SPENT BY MY INSURANCE CARRIER FOR THESE ENLITE SENSORS THAT ARE TIME SENSITIVE - AND THERE APPEARS TO BE NO RECOURSE. SINCE "THE BLAME" HAS BEEN PLACED WITH THE FDA, I HAVE NO WHERE ELSE TO TURN TO RECTIFY THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370623 INSULIN PUMP PARADIGM 551 INSULIN PUMP OZO MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR