Novo Nordisk Warns of Possible Cracks in Insulin Devices

Posted 05 July 2017 By Zachary Brennan

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Novo Nordisk A/S on Wednesday warned people with diabetes that it has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, including certain cleaning agents.

Novo spokesman Ken Inchausti told Focus that this is a global recall.

Certain lots of the two devices distributed in Canada were the subject of an initial warning. Other lots distributed in the US were part of another warning released Wednesday afternoon.

Novo Nordisk says it "has received numerous complaints of damaged cartridge holders and has received some reports of adverse events to date.

"Using a device with a cracked/broken cartridge holder can result in the device delivering a smaller dose of insulin than expected and may lead to high blood sugar," Novo said in a statement. "The risk of experiencing high blood sugar with the use of a device with an affected cartridge holder is evaluated to be less than 0.1 per cent, i.e. one in 1,000 patients will experience high blood sugar due to an affected cartridge holder."

Novo Nordisk urged those using devices from one of the affected lots to replace the cartridge holder, as some could be damaged or subject to damage in the future.

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Categories: Medical Devices, Crisis management, Due Diligence, News, US, Canada

Tags: Novo Nordisk, insulin pen, insulin device, NovoPen Echo, NovoPen 5

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