BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 885155 · Received July 19, 2007

    Report

    Report Number
    MW5003098
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Report Date
    July 19, 2007
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON A MEDTRONIC INSULIN PUMP 512, I HAVE HAD THE FOLLOWING SOFTWARE GLITCH APPEAR MANY TIMES. IF SOMETHING AS SIMPLE AS THIS CAN'T BE DONE CORRECTLY, IT HAS ME WONDERING WHAT OTHER "GLITCHES" EXIST IN THE SOFTWARE. WITH THE PUMP YOU CAN ENTER A BOLUS VALUE BY NAVIGATING THE MENUS. ON THE SCREEN WHERE YOU ARE ABLE TO SELECT A VALUE FOR THE BOLUS THE UP AND DOWN ARROWS FUNCTION TO ADJUST THE VALUE. THE DEFAULT VALUE IS 0.0 UNITS. WHEN THE USER PRESSES UP THE NUMBER INCREASES, DOWN DECREASES. THE VALUE LOOPS SO THAT WHEN YOU ARE GOING DOWN WHEN IT HITS 0.0 THE NEXT VALUE WILL BE YOUR MAX BOLUS VALUE AS DEFINED IN THE PUMP'S SETTINGS. THE ROLLING OVER FROM 0.0 TO MAX BOLUS VALUE MAKES IT VERY EASY TO ENTER LARGE VALUES QUICKLY, THIS IS IMPORTANT BECAUSE MOST MEALS ARE LARGE VALUES. THIS FEATURE IS VERY IMPORTANT TO THE USER. THE PROBLEM IS THAT IN SOME CASES, THE DOWN BUTTON WON'T FUNCTION FROM THE INITIAL VALUE OF 0.0. THIS ROLLING BACK FEATURE WORKS MORE THAN 98% OF THE TIME CORRECTLY, BUT IT DOESN'T ALWAYS WORK. AS STATED BEFORE, THIS INCONSISTENCY IS A CONCERN. IF SOMETHING AS SIMPLE AS THIS DOESN'T WORK CORRECTLY 100% OF THE TIME, WHAT ELSE IN THE PUMP'S SOFTWARE DOESN'T WORK RELIABLY?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP LZG PARADIGM 512

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR