The Accu-Chek® FlexLink Plus infusion set is being recalled by Roche Insulin Delivery Systems because the cannula can become bent or kinked when inserting the device, according to the U.S. Food and Drug Administration (FDA). If this happens, patients may receive too little insulin, leading to elevation of blood glucose levels, and a condition called hyperglycemia.
Roche Insulin Delivery Systems emphasizes that this recall only applies to the Accu-Chek® FlexLink Plus infusion set that was launched in November 2010. 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.
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. 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 their healthcare team or contact their physician.
If left untreated, hyperglycemia could lead to Diabetic Ketoacidosis (DKA); other serious illnesses; and, in severe cases, death.
Roche Insulin Delivery Systems is advising all customers to discontinue use of the Accu-Chek® FlexLink Plus infusion set and to contact their physicians or caregivers to determine if any changes to their therapy are needed.
Patients should also contact the local Accu-Chek® Customer Care, toll-free, at 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 resolved, the Accu-Chek® FlexLink Plus infusion sets will not be available.