#Implantfiles | Defective Insulin Pumps: Hospitals Stepped In To Alert

Delhi-based lawyer Alishan Naqvee’s daughter has been using an insulin pump ever since she was diagnosed with Type-1 diabetes at age six. She is now nine years old, able to carry out the activities you would expect of a child with the help of a small electronic device that infuses insulin into her body through the day.

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In September 2017, her father recalls, they received an email from Medtronic about an international recall of its MiniMed infusion insulin set, stating that these would be replaced for all patients using them.

“When the email came, we had three or four spare infusion sets. The company representative came the same day and gave us replacements. Medtronic is the only company that supplies insulin pumps in India and this is the one we have been using for our daughter all along,” said Naqvee.

Shrey Ahuja, a 22-year-old who lives in Delhi, says he was diagnosed with diabetes when he was almost three years old. He has been using the Medtronic insulin pump since age nine. “In my case, Medtronic replaced the spare cannulas which are attached to the body to infuse the insulin. We had almost three full boxes of cannulas at home and all were replaced free of charge,” he said.
There is no listing of this recall on the website of the Central Drugs Standard Control Organisation (CDSCO), which is meant to regulate recalls by displaying “medical advice alerts” but has only 23 medical devices on its notified roster.
The insulin pump recall, in a nutshell, captures the essence of the Implant Files, an investigation by the International Consortium of Investigative Journalists (ICIJ) and 59 media houses including The Indian Express, which exposed how almost every medical device is advertised, sold, and surgically implanted under regulatory systems that, effectively, don’t exist.

Introduced in India in 2000, the Medtronic device 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.
In September 2017, Medtronic announced it was recalling specific batches of its MiniMed devices. The company stated that they found the device could trigger an excessive amount of insulin, resulting in possible hypoglycaemia. It said about 10,000 infusion sets were being recalled in India from notified batches.
Specifically, as part of the FDA recall, the company said the infusion sets used with its insulin pumps were being voluntarily recalled due to problems with a discontinued component. The problem, it said, involved a vent membrane susceptible to blockage during priming and fill-tubing. No pumps or glucose sensors were affected by the recall. Infusion sets made since April 2017 use an updated vent membrane design.

Responding to queries from The Indian Express, a Medtronics spokesperson stated: “The complete infusion sets were recalled and replaced in India. A total of 326 patients in India were affected and all of them were informed — advised and the product was replaced to their satisfaction.”

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But senior diabetologists in Delhi say Medtronic was not so proactive at the time of the Minimed infusion set recall. Dr Amrita Ghosh of Fortis-C-DOC Centre of Excellence of Diabetes, who handles insulin pump therapy at the hospital, says they were the ones who noticed the news of the recall by the US Food and Drug Administration (FDA) and informed Medtronic about it.

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“We have created a toll-free group for patients who use the Medtronic insulin pump and this news was also circulated by us on the group. In all, there were about seven or eight patients who were using pumps of the relevant batch and it was after our intervention that Medtronic contacted them. Shrey Ahuja was one among those who got the replacements,” said Ghosh.

Senior endocrinologist, Dr Ambarish Mittal, says he had heard about the Medtronic recall. According to him, even if the cannula tip or the infusion wire goes faulty and there is rush of insulin or lack of it in the body, it can do a lot of damage.

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