FOR IMMEDIATE RELEASE - February 21, 2011 -Roche Insulin Delivery Systems announced today that it is notifying its customers and healthcare professionals about the recall of the ACCU-CHEK® FlexLink Plus infusion set, because of the potential for under delivery of insulin due to a kinked/bent cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. If this remains unnoticed, this can result in under delivery leading to elevation of blood glucose levels.
The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain. If untreated hyperglycemia could lead to Diabetic Ketoacidosis (DKA), serious illnesses and in severe cases death. Patients experiencing these symptoms are advised to check their blood glucose to ensure that the blood glucose level is within an acceptable range as defined by the patient’s healthcare team and to follow the medical advice given by the their healthcare team or contact their physician.
Roche Insulin Delivery Systems advises all customers to discontinue use of ACCU-CHEK ® FlexLink Plus infusion set and to contact their physicians or caregivers to determine if any changes to their therapy are needed and the local ACCU-CHEK ® Customer Care 1-800-688-4578 to receive support on obtaining alternative infusion sets, such as the ACCU-CHEK Tender or ACCU-CHEK Rapid-D infusion set. Until this issue is fixed, the ACCU-CHEK ® FlexLink Plus infusion sets will not be available.
Roche Insulin Delivery Systems emphasizes that the above mentioned action only applies to the ACCU-CHEK ® FlexLink Plus infusion set that was launched in November 2010. The use of the previous version ACCU -CHEK ® Ultraflex, other Accu-Chek® infusion sets or insulin pumps are not affected and insulin pump therapy can be continued as directed with these products or other alternatives.
Mark, is this recall only for the U.S. I use flex link but it doesn’t say flex link plus. I live in Ireland so supplies might come from U.K. Any thoughts?
Colette, The recall is only for “PLUS” infusion sets…they came out in the US in November. I was told that they were phasing out the standard “FLEXLINK”… Mark
Me too Colette. When I read this I thought it might explain high blood sugars this week that I have no idea where they came from! Oh well… I have no explaination for them now because I also use the FlexLink, not the FlexLink Plus. Interesting that the are phasing out the FlexLink but they havent brought out the FlexLink Plus ones here yet…
funny enough, when I started therapy on the 15th of this month these were the sets I was started on. and the first 3 days of therapy were hell! Both of the sets that I used were kinked on removal, and my b.g. did get to astronomical numbers! Glad to know it wasn’t just my beginner’s technique…
This is Rob Muller from Roche. First, thank you, Mark, for posting the recall notice and getting the word out. Second, we deeply regret any problems this may have caused.
If there is any question about your Accu-Chek infusion set, please call our customer care line. In the U.S., that number is 800-858-8072 and it’s open 24 hours a day.
Rachel, if you haven’t done so yet, please call the number above and explain your issues so we can do our best to remedy the situation.
Colette, to answer your question, this is a global recall. To insure the most accurate information, please call your local customer care center at 1 800 709 600 and ask if your infusion set is part of the recall.
If there is anything else I can help with, please send me a message here, or email me directly at rob.muller@roche.com
