(Bloomberg) -- Medtronic Plc is recalling a disposable device used with the company’s insulin pumps, after discovering that the part can trigger an excessive dose of the drug and put patients at risk of hypoglycemia.
About one in every two million infusion sets manufactured before April may be associated with the complication, which occurs when a membrane that’s used to release pressure from inside the pump gets wet and blocks the vents, said Francine Kaufman, chief medical officer of Medtronic’s diabetes group. The risk of an excessive insulin dose is greatest right after the patient changes the infusion set, which is done every three days, she said.
“Shortly after that change, the patient could experience insulin over-delivery,” she said in a telephone interview.
There haven’t been any deaths associated with the flaw, Kaufman said. Most patients who had a problem were aware that their blood sugar had gone too low and were able to treat the condition. Others called an ambulance, went to the hospital or saw their doctors, she said.
For patients with an infusion set that is in and working, nothing needs to be done, said Annette Bruls, president of Medtronic’s diabetes service and solutions business. Medtronic says it has fixed the problem and patients can use the devices that were made from April on.
Medtronic, based in Dublin and run from Minneapolis, said the majority of the cost from the recall is expected to be incurred in the second quarter of the company’s fiscal year and will depend on the amount of unused sets that patients return. It isn’t expected to reduce earnings in the quarter or the full year, or impact revenue growth in the diabetes group, the company said.
The company established a website that will allow patients to check if the infusion sets they have on hand are part of the recall. It will exchange older sets for free.
It’s difficult to know how many of the older sets are still on patients’ or drugstore shelves, Bruls said. The company tracks patient orders and will send the updated device to some people who haven’t recently gotten them, along with the letter informing them of the recall.