Description of Event or Problem · 1
IN (B)(6) 2010, I WAS SENT A NEW ORDER OF INFUSION SETS BY ROCHE INSULIN DELIVERY SYSTEMS. -AC FLEXLINK PLUS- WHICH WAS REPLACING THEIR ACCU-CHECK ULTRAFLEX. OVER THE PAST FEW YRS, I HAVE NOT HAD ANY INFUSION SET PROBLEMS AND MY A1C HAS BEEN AT THE 7.0 LEVEL. WHEN I STARTED WITH THE NEW INFUSION SETS, I BEGAN TO HAVE SEVERE PROBLEMS WITH MY BLOOD SUGARS LEVELS. I CALLED ROCHE AND EXPLAINED THE DIFFICULTIES. THEY GAVE ME INSTRUCTIONS OVER THE PHONE, BUT WAS NOT ANY DIFFERENT FROM WHAT I HAD BEEN DOING. I CONTINUED TO HAVE PROBLEMS, CHANGING THE INFUSION SET EVERY 2 INSTEAD OF 3 DAYS. THE TUBE THAT ENTERED MY SKIN WAS BENT ABOUT 90% OF THE TIME AND I WAS BECOMING VERY FRUSTRATED. I ALSO CALLED MY DIABETIC PHYSICIAN'S OFFICE TO SEE IF THEY HAD ANY SUGGESTIONS. I STARTED GIVING MYSELF ADDITIONAL SHOTS MANUALLY TO BRING DOWN MY ELEVATED SUGARS. MY SUGARS WENT INTO THE 500'S, WHICH HADN'T HAPPENED IN YRS. I STARTED THE PROCESS OF GETTING A NEW PUMP THINKING THAT IT WASN'T WORKING. I ORDERED ANOTHER BOX OF INFUSION SETS AND THEY SAID THAT THEY WERE BACKORDERED. I REQUESTED THE OLD INFUSION SETS, WHICH THEY WOULDN'T SEND BEFORE, BUT FOR SOME REASON THEY HAD THEM ON HAND AGAIN. SO, SINCE I HAVE BEEN USING THE NEW SETS, MY SUGARS HAVE RETURNED TO MY USUAL READINGS. I BASICALLY HAD 2 HORRIFIC MONTHS OF HIGH SUGARS WHICH COULD HAVE INCREASED MY CHANCES OF DIABETIC SIDE AFFECTS. MY A1C ROSE TO 8.2 WHICH I HAVEN'T SEEN IN YRS. I'M VERY NERVOUS ABOUT WHAT THIS HAS DONE TO MY LONG TERM HEALTH. I RECEIVED A NOTICE TODAY THAT THESE INFUSION SETS HAVE BEEN RECALLED-THANK YOU. THIS PROBLEM COSTS ME ADDITIONAL MONEY BECAUSE I USED MORE INFUSION SETS AND MANY MORE TEST STRIPS FOR THE BLOOD GLUCOSE METER, TRYING TO GET MY BLOOD SUGARS BACK TO NORMAL. DATES OF USE: (B)(6) 2010 - (B)(6) 2011.