BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINIMED PARADIGM 511

    MDR report key: 769070 · Received October 12, 2006

    Report

    Report Number
    MW1040652
    Event Type
    Other
    Date Received
    October 12, 2006
    Date of Event
    September 17, 2006
    Report Date
    September 26, 2006
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY MINIMED PARADIGM 511 INSULIN PUMP FAILED APPARENTLY WITHOUT MY KNOWLEDGE. A BUTTON WAS DEPRESSED AND BECAME STUCK -STOPPING THE PUMP. MINIMED WILL NOT REPAIR THIS PUMP. THEY WILL ONLY SELL NEW PUMPS. MINIMED REPLACED MY NEW PUMP WHEN IT FAILED WITH A REFURBISHED PUMP. THIS HAPPENED ANOTHER TIME SO I HAD A TOTAL OF 1 NEW AND 2 REFURBISHED PUMPS OVER THE 4 YR WARRANTY TIME. NO ADD'L WARRANTIES WERE PROVIDED WITH THE REFURBISHED PUMPS. PROBLEMS - NO ADD'L WARRANTY WITH REFURBISHED PUMP. UNABLE TO REPAIR A BUTTON ON A PUMP. I CONTACTED MFR FOR SPECIFIC REPAIR INSTRUCTIONS WITH NO REPLY. I DON'T UNDERSTASND HOW MINIMED CAN REPAIR PUMPS AND SEND THEM OUT TO PTS AS REPLACEMENTS BUT CANNOT REPAIR PUMPS FOR PTS EVEN WHEN REPAIR WOULD BE PAID BY PT. I NOW OWN AN INSTRUMENT THAT DOESN'T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM 511 MINIMED INSULIN PUMP LZG MEDTRONIC MINIMED PARADIGM 511 IPX7P6024600-319

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other