Description of Event or Problem · 1
I HAVE A WELL KNOWN INSULIN PUMP THAT SHOULD HAVE BEEN REPLACED BACK IN (B)(6) 2012, (ACCORDING TO THE MANUFACTURER'S OFFICE ON A RECORDING) BUT WAS NOT. IT CAUSED MY A1C TO GO FROM 6.9 TO 8.1. THE CAUSE WAS THE PUMP OUT PULSED THE WRONG METER READINGS TO THEIR SOFTWARE WHICH WAS USED BY MY ENDOCRINOLOGIST, THE SAME SOFTWARE HE USES FOR ALL OF HIS PTS, ALONG WITH ALL PTS NATIONWIDE. THIS IS THE SAME MAJOR SOFTWARE THAT SHOWS THE DAILY PATTERN OF THE PUMP USER. THEN THE ENDOCRINOLOGIST WILL PROVIDE THE PROPER INSULIN REGIMEN BASED ON THAT PATTERN. HOWEVER, IF THE PUMP PRODUCES THE WRONG GLUCOSE NUMBERS AND MISSING NUMBERS THEN THE ENDOCRINOLOGIST WILL BE PRESCRIBING THE INCORRECT INSULIN PROGRAM FOR THE PUMP WHICH WILL AFFECT THE USER'S A1C. MINE WENT FROM 6.9 TO 8.1. IN MY CASE, IN ONE DAY, I HAD GLUCOSE LEVELS OF 221, 254, 86 AND 304 THAT NEVER APPEARED ON THE REPORT AND HE ONLY SAW RANGE NUMBERS SO MY INSULIN PROGRAM WAS SET ONLY ON THE NUMBERS HE ONLY SAW WHICH CAUSED MY A1C TO RAISE TO 8.1 FROM 6.9. I HAD SUGAR LOWS DOWN TO 50 AND HIGHS UP TO 550. THE BOTTOM LINE IS THE PUMP MANUFACTURER IS NOW AWARE OF THEIR SOFTWARE/METER MALFUNCTION AND REFUSES TO ACT ON IT. IT CAUSED MY A1C TO RISE AND IT IS PUTTING OTHER USERS THAT MIGHT HAVE THE SAME SITUATION THAT I WAS IN A SERIOUS LIFE THREATENING SITUATION. I SPOKE TO THE MANUFACTURER'S OFFICE AND THEY REFUSE TO TELL THEIR PTS ABOUT THIS MALFUNCTION, WHICH I DISCOVERED. TO KEEP ME CALM ABOUT THEIR SOFTWARE/METER MALFUNCTION, THEY GAVE ME A NEW PUMP FOR FREE. I HAVE THE SOFTWARE AND COPIES OF METER READING THAT CAN BE MATCHED UP TO VERIFY THE FACT THE REPORT IS IN SOME CASES CORRUPT, WHICH MEANS THE PUMP IS NOT WORKING AND NEEDS TO BE REPLACED. I DO NOT BELIEVE I AM THE ONLY PERSON IN THE WORLD THAT HAS THIS PROBLEM, HOWEVER, THIS NEEDS TO BE USED BY THEIR TECHS AS A DOUBLE CHECK WITH ALL PUMP USERS TO VERIFY IF THE PUMP IS WORKING PROPERLY. ALL THEY HAVE TO DO IS: ASK THE PUMP USER TO DOWNLOAD THEIR PUMP TO THEIR SOFTWARE; MATCH THE METER READINGS TO THE DAYS AND TIMES ON THOSE REPORTS; IF THERE ARE ANY MISSING READINGS OR IF THERE ARE ANY READINGS THAT APPEAR THAT DO NOT APPEAR ON THEIR METER, THEN PUMP IS NOT WORKING AND IT NEEDS TO BE REPLACED. THE COMPANY DOES NOT WANT THIS TO HAPPEN, THEY DO NOT WANT THE CUSTOMERS TO KNOW. THEY DO NOT WANT THE FDA TO KNOW. THEY DO NOT WANT ANYBODY TO KNOW! THIS WILL HURT ANYONE THAT HAS THIS TYPE OF PROBLEM: (B)(6) AT 9:09AM MY METER SHOWS GLUCOSE READING OF 86 IS NOT ON THE REPORT. (B)(6) 9:15PM MY METER SHOWS GLUCOSE READING OF 304 IS NOT ON THE REPORT. THESE ARE ONLY TWO OF MANY ON THAT DAY AND I HAVE NUMEROUS READINGS MISSING AND SHOWING UP THAT NEVER HAPPENED ON THE REPORT FROM (B)(6) 2013. IF YOU WERE AN ENDOCRINOLOGIST, HOW IMPORTANT WOULD IT BE TO KNOW THAT ON ONE DAY YOUR PT HAD A 86 LOW AND A 304 HIGH YOU NEVER KNEW ABOUT, AND THEN YOU PRESCRIBED THE WRONG INSULIN REGIMEN THAT CAUSED YOUR PT A1C TO RAISE, OR WORSE, GO INTO A DIABETIC COMA? ALL BECAUSE THE REPORT FROM THE PUMP WAS WRONG! I HAVE THE REPORTS AND READINGS FROM (B)(6) 2013.