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Monday, July 13, 2020

#ImplantFiles | Defective insulin pumps: Hospitals stepped in to alert

326 patients affected; Medtronic says 10,000 units withdrawn in India

Written by Ritu Sarin | New Delhi | Updated: November 29, 2018 8:34:22 am
implant files, breast implant, implant files investigations, medical implants, Stryker India, medical implants india, FDA, US FDA, sale of implants in India, cardiac stents india, pacemaker india, breast implants india, implants industry india, ICIJ, Indian Express Outside the Medtronic office in Mumbai. The firm claims it alerted all patients. (Express Photo)

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.

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.

#ImplantFiles: On US blacklist, in India they are in the grey zone

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.

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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.”

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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“Though these are the smallest cogs in the insulin pump system, it can create havoc for a patient. So immediate notification, in this case by Medtronic, is imperative as is the immediate replacement of the recalled pump or part of the insulin set,” said Mittal.

“I learnt about the FDA recall through a WhatsApp group of parents whose children are using the insulin pump. Medtronic did not contact us and we learnt about the recall only four months after it happened,” said the father of a 10-year old diabetic who used the device.

The father, who is a doctor in Jalandhar, says that it later turned out that the batch of the pump that his son was using was not among those recalled. “But suppose it was part of the defective batch and an incorrect dose was being given to my son, it could have been a serious matter. In India, these things are not taken seriously and the company did not act responsibly,” he said.

‘Voluntary recall, informed all patients’

Responding to a questionnaire from The Indian Express on the insulin pump recall, a Medtronic spokesperson stated:
”Specific lots of MiniMed insulin infusion sets (which are used as one of the accessories with Medtronic insulin pumps) were voluntarily recalled in September 2017. The device is an infusion set which 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.

“It was a voluntary recall — where Medtronic proactively informed the FDA about the issue and initiated the replacement process. As a process, we sent out notifications to patients along with their corresponding healthcare providers.

“A special web page was created where patients could determine if their infusion sets were part of the recall. The web page also contained detailed information about arranging for the return of product. Beside the website, patients could dial a toll free number and easily speak to a member of our team or our distribution partners who could help arrange for return and replacements of the recalled infusion sets.

“All recalled products were exchanged at no cost. Around 10,000 units were recalled from India of which around 97% were either at our warehouse or with the distribution partners.

“Communication through various medium was sent out to physicians, patients, patient-groups, distributors informing them about the recall. All necessary information like details of the web page, toll free number and India specific email id were mentioned in our communication to all stakeholders who are involved in process related to diabetes/ insulin pump. As the product is a disposable product of a wearable device, all customers were again informed about the change when they reached out to the distributors for repeat purchase about this change.

“The safety of our patients is our top priority. Considering safety of our patients, we voluntarily initiated a recall of specific lots of infusion sets used with Medtronic insulin pumps. We worked in close collaboration with the authorities/distributors/physicians during the process of recall. We also sent a specific advisory to leading hospitals/clinics across the country.

“Additionally, we have multiple channels of communications with patients and caregivers like webpage, toll free number or email; through which patients can easily contact us and get required information.

“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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