BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINIMED GUARDIAN

    MDR report key: 1467862 · Received September 5, 2009

    Report

    Report Number
    MW5012614
    Event Type
    Other
    Date Received
    September 5, 2009
    Date of Event
    September 5, 2009
    Report Date
    September 5, 2009
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM USING THE MEDTRONIC MINIMED "GUARDIAN" CONTINUOUS GLUCOSE MONITORING SYSTEM. I HAD TURNED THE SYSTEM OFF OVERNIGHT, AND INSERTED A NEW SENSOR JUST BEFORE LUNCH. SHORTLY THEREAFTER, THE SYSTEM EXPERIENCED A COMMUNICATIONS ERROR, AND LOST THE SENSOR'S RADIO SIGNAL. WHEN I LOOKED AT THE STATUS SCREENS ON THE DEVICE, THE DEVICE REPORTED THAT THE SENSOR WAS 1 DAY AND 12 HOURS OLD. TO BE CLEAR, THE SENSOR WAS ABOUT 15 MINUTES OLD. I CALLED MEDTRONIC MINIMED, AND THEY CLAIM THAT THE SYSTEM IS FUNCTIONING AS NORMAL. THIS IS RIDICULOUS. IN ADDITION TO THIS, THE MEDTRONIC MINIMED SYSTEM STATES THAT THE USER WILL NEED TO WAIT A SPECIFIED AMOUNT OF TIME -EITHER 15 MINUTES, OR 2 HOURS- AND THEN LATER VIOLATES ITS STATEMENT BY RESUMING FUNCTION EITHER SHORTER OR LONGER THAT THE SPECIFIED TIME. THE MESSAGES THE DEVICE DISPLAYS DO NOT MAKE USABILITY CLEAR. FURTHER, IF YOU CALL MEDTRONIC MINIMED, THEY ARE HAPPY TO SUPPLY YOU WITH ADDITIONAL, HIGHLY RELEVANT INFO -WHICH IS NOT IN THE MANUAL- WHICH IMPROVES ACCURACY AND USE OF THE DEVICE. I BELIEVE THIS IS IRRESPONSIBLE OF THEM. USERS SHOULD, AT MINIMUM, BE ABLE TO ACCESS THIS INFO ON THEIR WEBSITE. THIS IS DISCRIMINATORY TO DEAF AND HARD-OF-HEARING USERS, WHO ARE LESS LIKELY TO CONTACT A CALL CENTER, AND MORE LIKELY TO RELY ON THE MANUAL. ON A FINAL NOTE, I WISH THE FDA WOULD ADVOCATE FOR PATIENTS. COMPANIES LIKE MINIMED RUSH TO GET A DEVICE TO MARKET, AND FAIL TO CONSIDER PRINCIPLES OF USABILITY/DESIGN. THERE ARE SPELLING MISTAKE IN THE MANUAL, AND IT'S NOT ONLY WITH MINIMED THAT I HAVE OBSERVED THIS PHENOMENON. HONESTLY, IT'S MADLY FRUSTRATING, AND THE FDA IS THE ONLY ONE POSITION TO STOP IT. FOR EXAMPLE, THE PRODUCT ALLOWS ME TO LOOK AT THE ERROR MESSAGES I'VE RECEIVED, REPORTING THAT I GOT A "DWNSLP" ERROR AT 8:40 PM YESTERDAY. THE MATCHING ERROR MESSAGE -DISPLAYED AT 8:40- SAID SOMETHING ALONG THE LINES OF "FALL RATE: THE SENSOR IS FALLING AT RATE THAT IS EQUAL TO OR FASTER THAT THE USER SPECIFIED RATE LIMIT OVER THE USER SPECIFIED TIME PERIOD." GEESH. "FALL RATE" DOES THE TRICK, AN, A COUPLE HOURS/DAYS LATER, MOST USERS WILL BE UNABLE TO LINK "FALL RATE" TO "DWNSLP" -WHICH LIKELY STANDS FOR "DOWNWARD SLOPE" AND DOES NOT APPEAR IN THE MANUAL'S INDEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED GUARDIAN GUARDIAN MDS MEDTRONIC MINIMED GUARDIAN 7100

    Patients

    Seq Age Sex Outcome Treatment
    1