Medtronic recalls some MiniMed insulin infusion devices
New Delhi: Multinational medical device maker Medtronic Plc has recalled specific lots of infusion device (MiniMed) used with its insulin pumps, a move likely to have an impact on India, often called the diabetes capital of the world.
The 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 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. The product was launched in India in year 2000.
“It appears that some batches of infusion sets used in the insulin pump we use for patients for Type 1 diabetes are being recalled by the company in other countries; however, till date, we have not faced any problems with currently active pumps that we have installed. We shall keep all these patients under close observation,” said Dr. Anoop Misra, chairman at Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology.
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.
According to a Medtronic spokesperson, approximately 10% of infusion sets may be recalled. While around 5,000 sets are getting recalled from India, 90% of them are being exchanged at the distributor warehouse.
“However, it is difficult to predict exactly how many unused, recalled infusion sets are in customer hands that will need an exchange,” said the company spokesperson.
The Dublin-based company stated that they have updated the US Food and Drug Administration (FDA) along with other regulatory bodies in the world on the issue. “Medtronic will continue working directly with government and regulatory authorities on this global voluntary recall,” added the release.
“The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypogycemia,” the company further said.
The company asked the customers to check online to determine whether they have infusion sets that have been recalled, adding that it will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component for free.
“Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic in a statement. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.”
The company also clarified that the currently manufactured infusion sets, available to patients since April 2017 include a “design update” of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. Medtronic recommended that customers use only infusion sets made with the new and enhanced component, called the membrane.
The recall-they said is “not expected to reduce earnings in the quarter or the full-year, or impact revenue growth in the Diabetes group”.