Description of Event or Problem · 1
FIRST AND FOREMOST, LET ME LAUD YOU FOR THE RECENTLY LAUNCHED INFUSION PUMP IMPROVEMENT INITIATIVE. I HAVE BEEN A TYPE 1 DIABETIC FOR OVER 35 YEARS. I SWITCHED FROM MULTIPLE DAILY INJECTIONS OF INSULIN TO THE MEDTRONIC MINIMED PARADIGM INSULIN PUMP, STARTING ON (B)(6) 2008. MY INITIAL EXPERIENCE WAS VERY ROUGH. ON (B)(6) 2008, I WROTE TO THE FDA MEDWATCH PROGRAM BECAUSE I WAS SO CONCERNED ABOUT: MISREPRESENTATION OF CERTAIN ASPECTS OF PUMP THERAPY AND NONDISCLOSURE OF POTENTIAL PROBLEMS DESPITE SPECIFIC QUESTIONS THEREON, INADEQUATE TRAINING AND SUPPORT, INCORRECT INSTRUCTIONS IN THE USER GUIDE TO THE PUMP AND INSERTION SETS, AND INCORRECT INFORMATION GIVEN BY MEDTRONIC'S 24 HOUR HELP LINE. I HAVE OFTEN OVER THE PAST TWO YEARS BEEN FRUSTRATED BY WHAT I SAW AS POORLY DESIGNED ASPECTS OF THE PUMP, AND I RECENTLY ENCOUNTERED ANOTHER PROBLEM THAT PROMPTED ME TO CONSIDER WRITING TO MEDTRONIC AND TO THE FDA, ESPECIALLY IN LIGHT OF YOUR INITIATIVE. MEDTRONIC RECENTLY RELEASED SURE-T INFUSION SETS THAT ARE ADVERTISED AS HAVING 32" LENGTH TUBING (INFUSION SETS MMT-866). IN FACT, THE TUBING LENGTH ON ALL THE SETS THAT I HAVE RECEIVED (AND I HAVE NOW OPENED SETS FROM SIX DIFFERENT BOXES AND TWO DIFFERENT LOT NUMBERS) ARE 23-24" IN LENGTH WITHOUT THE TAIL AND 27-28" IN LENGTH INCLUDING THE TAIL. ASIDE FROM MEDTRONIC'S UNRESPONSIVENESS AS I QUESTIONED THIS, WHICH I HAVE RAISED WITH THEM, AND ACKNOWLEDGING THAT THIS PARTICULAR ISSUE DOES NOT DIRECTLY AFFECT MY HEALTH, NONETHELESS, IT HAS RAISED SERIOUS QUESTIONS IN MY MIND ABOUT THE COMMITMENT TO QUALITY CONTROL, THEIR STANDARDS AROUND QUALITY CONTROL, AND THEIR ETHICS. TO USE AN ADMITTEDLY SIMPLE EXAMPLE, IF I WENT TO A STORE AND BOUGHT 32 FEET OF CARPET AND I GOT HOME AND IT TURNED OUT THEY ONLY GAVE ME 27 FEET, THAT WOULD BE UNACCEPTABLE. WHILE IT MIGHT NOT THREATEN MY HEALTH, I THINK MOST PEOPLE WOULD AGREE THAT IN THIS SITUATION, THE STORE BEHAVED DISHONESTLY, UNPROFESSIONALLY, UNETHICALLY, AND QUITE POSSIBLY, ILLEGALLY. IS THERE ANY REASON WHY A MEDICAL DEVICE COMPANY SHOULD NOT BE HELD TO AS HIGH OR A HIGHER STANDARD? I WOULD ENCOURAGE YOU TO HOLD ALL MEDICAL DEVICE COMPANIES, AND THE DEVICES THAT THEY SELL AND MANUFACTURE, TO THE MOST EXACTING STANDARDS. I WOULD ALSO ENCOURAGE YOU TO BROADLY GATHER FEEDBACK ABOUT USABILITY ISSUES FROM INTERESTED USERS OF MEDICAL DEVICES SUCH AS MYSELF. IF THERE IS AN APPROPRIATE FORUM FOR ME TO SHARE MY THOUGHTS ON THIS TOPIC AS YOU PROCEED WITH THE INFUSION PUMP IMPROVEMENT INITIATIVE, PLEASE LET ME KNOW.