Medtronic recalls Lots Of MiniMed Insulin Infusion Device From India
Medtronic, the multinational medical device maker has reportedly recalled specific lots of its ‘MiniMed’ infusion sets used with all models of its insulin pumps globally, including 5,000 sets from India. The Dublin-based company started the recall after it found the device could trigger an excessive dose of the drug and put patients at risk of hypoglycemia, a condition where blood sugar falls below normal levels.
The infusion sets under recall were launched in India in early 2000, around 90% of the sets recalled from India are being exchanged at the distributor warehouse. Medtronic has enough infusion sets to provide all customers who need replacements with the product “as soon as possible” and will be able to maintain ongoing orders of infusion sets, a company spokesperson said.
The device, which is used mostly in children with Type I diabetes, delivers precise, timely insulin, similar to the way healthy pancreas delivers insulin in the body. There are around 4,000 patients benefiting from the innovative insulin pump therapy in India. However, with the company announcing recall, doctors in India say they will have to keep a close watch on their patients.
Type I
diabetes occurs when the immune system destroys cells in the pancreas that make insulin. Other than children, the pump is used in those patients where insulin producing cells have been destroyed. An infusion set consists of a disposable tube, a tubing connector and a cannula, typically inserted under the skin in the abdominal area, which delivers insulin from the pump to the body of a person with diabetes.Medtronic has contacted the U.S. Food and Drug Administration (FDA) as well as regulatory bodies in other countries about this issue. “Because insulin over-delivery can pose significant safety issues for customers, we voluntarily initiated this recall of specific lots of infusion sets used with Medtronic insulin pumps,” the spokesperson said.
Currently manufactured infusion sets include a design update of this component that may reduce the risk of insulin over-delivery after an infusion set change, according to the company. This has been made available to patients since April 2017. The voluntary recall is not expected to impact Medtronic’s ‘Diabetes Group’ revenue growth in the second quarter or the full fiscal year, stated the company in its global release.
