BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 2887581 · Received December 16, 2012

    Report

    Report Number
    MW5028303
    Date Received
    December 16, 2012
    Date of Event
    August 1, 2012
    Report Date
    December 16, 2012
    Manufacturer
    MEDTORNIC MINIMED
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MINIMED PARADIGM INSULIN PUMPS ARE CONTINUOUSLY HAVING PROBLEMS THAT REQUIRE REPLACEMENT WAY TOO FREQUENTLY. THIS IS COMING FORM A USER OF AN INSULIN PUMP WHO IS ALSO A DIABETES EDUCATOR AND RN MYSELF, AND KNOWS OF OTHER PEOPLE WHO ARE HAVING SIMILAR PROBLEMS. I HAVE HAD TO REPLACE 4 INSULIN PUMPS IN LESS THAN 6 MONTHS. THE CURRENT REPLACEMENT MAY HAVE TO BE RETURNED AFTER ONLY A WEEKS OF USE AS WELL, MAKING THE NUMBER 5 REPLACEMENTS IN ABOUT 5 MONTHS. I HAVE NOT DONE ANYTHING TO THESE PUMPS THAT WOULD HAVE LED TO DAMAGE: I.E. NEVER GOT THEM WET, NEVER PUT THROUGH X-RAY, NOT HIT, ETC. EACH TIME THE PROBLEM IS SOMETHING DIFFERENT, AND MAY TIMES HAS LED TO COMPLETE FAILURE OF PUMP TO FUNCTION PROPERLY. FOR EXAMPLE, THE FIRST PUMP I HAD TO REPLACE HAD A FROZEN SCREEN THAT COULD NOT BE FIXED AND INSULIN WAS NOT BEING DELIVERED. MY REPLACEMENT PUMP, AFTER ONLY BEING WORN FOR A FEW DAYS, HAD A FATAL ERROR THAT REQUIRES IMMEDIATE REPLACEMENT. IF THIS WOULD HAVE HAPPENED TO BE DURING THE MIDDLE OF THE NIGHT, I COULD HAVE NEVER WOKEN UP. I AM TYPE 1 DIABETIC AND CAN GO INTO DKA WITHIN HOURS OF NOT RECEIVING INSULIN WHICH CAN CAUSE ICU STAYS, DEATH. I FIRST USED A MINIMED PUMP 10 YEARS AGO, AND NEVER SAW SO MANY ISSUES WITH PUMPS AS I DO TODAY. I AM CONVINCED THAT THERE IS SOMETHING NOT BEING SUFFICIENTLY REGULATED IN THE SYSTEM. I AM NOT BEING TAKEN SERIOUSLY BY THE COMPANY AND THEIR ANSWER TO ME IS, "WE ARE NUMBER ON IN SALES, SO THERE MUST NOT BE A PROBLEM OVERALL WITH OUR PRODUCT." I UNFORTUNATELY THINK THAT COMPOUNDS THE PROBLEM. I FEAR THAT THEY HAVE TAKEN THE STANCE THAT SINCE THEY HAVE NO REAL COMPETITORS, THEY CAN BE LAX ON A MEDICAL DEVICE THAT COULD KILL PEOPLE IF NOT REGULATED PROPERLY. I AM HIGHLY CONCERNED FOR MYSELF AND FOR MY PTS, FRIENDS, AND COLLEAGUES WHO USE THEIR INSULIN PUMPS. THE FACT THAT EACH OF MY PUMPS HAS FAILED FROM SOMETHING DIFFERENT CONCERNS ME EXPONENTIALLY, SINCE THIS INDICATES IT IS NOT JUST ONE DEFECT, BUT INSTEAD A PROBLEM IN THE ENTIRE MANUFACTURING OR CHECKS AND BALANCES PROCESS AS A WHOLE. IN DIABETES CIRCLES, BOTH PTS AND EDUCATORS, THIS IS BECOMING MORE AND MORE KNOWN ABOUT THE NEWER MINIMED PUMPS, BUT UNFORTUNATELY I DO NOT THINK THAT MANY PEOPLE REPORT IT TO REGULATING BODIES. DOSE: APPROXIMATELY 60-100 UNITS DAILY/CONTINUOUS. DATES OF USE: (B)(6) 2010 - (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP LZO MEDTORNIC MINIMED PARADIGM 712

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other