Devices & Diagnostics

Roche diabetes recall centers on low delivery of insulin

The Roche diabetes recall centers on a lack of insulin delivered by Accu-Chek FlexLink Plus. A tube that delivers insulin develops kinks, according to the company. This Roche diabetes medical device won’t be available until the problem is fixed.

Roche Diabetes Care’s Insulin Delivery Systems unit issued a recall for one of its infusion sets while it tries to work out the kinks — literally.

There’s a possibility that its Accu-Chek FlexLink Plus will under-deliver insulin because the tube that delivers the medication, the cannula, can become kinked, according to the company.

Roche Insulin Delivery Systems notified its customers and healthcare professionals about the potential for the device to fail, the company said. The recall applies only to the Accu-Chek FlexLink Plus infusion set that was launched in Nov. 2010.

The recalled device won’t be available until the issues is fixed, according to Roche.

The under medication of diabetic patients could lead to the elevation of blood glucose levels, symptoms for which include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain, according to the company. If untreated, elevation of blood glucose levels, or hyperglycemia, could lead to Diabetic Ketoacidosis, serious illnesses and in severe cases death, the company said.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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