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Medtronic recalls disposable diabetes infusion sets over risk of causing hypoglycemia

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Medical device manufacturer Medtronic Plc is recalling disposable diabetes infusion sets as a possible defect may trigger excessive doses of insulin to the diabetic user, putting them at risk of hypoglycemia.

The recall reportedly affects insulin infusion sets distributed all over the world.

The device, connected to an insulin pump, features thin plastic tubing with a needle or cannula at the end to carry insulin into the body when needed. However, apparently, “one in every two million” sets may contain a “complication”.

There are at least 422 million people across this globe that suffer from diabetes, so a significant number may use the devices, meaning a proportion of sufferers may have a complication with their device. The possible defect is said to be in the “vent membrane” that could get blocked up and trigger an overdose of insulin. The membrane can be affected when insulin, alcohol or water is accidentally spilled on top of the insulin reservoir.

When there is too much insulin in the body, it can lower blood sugar levels significantly, which can put the person at risk of hypoglycemia. In extreme circumstances, this can lead to the person falling into a coma.

Chief medical officer of Medtronic’s diabetes group reportedly noted that the risk of overdose is highest when the user has just changed the infusion set, which is usually carried out every three days.

“Shortly, after that change, the patient would experience insulin over-delivery,” she admitted.

A recall of this nature needs to be issued effectively to ensure all users and carers are aware of the problems, and stop anyone from coming to harm. Medtronic have reached out to customers to check online and see if their infusion sets are affected.

Concerned U.K. patients or carers can check by clicking on this url: https://www.medtronic-diabetes-look.com/en_gb/check

Once the recalled devices are identified, the user should be able to request a replacement free of charge.

Medtronic makes the devices for countries all over the world, including the U.K. Here, we have around three million people who suffer from diabetes. The Diabetes U.K. Clinical Advisor, Emma Elvin, emphasises the importance for diabetics who use Medtronic devices to check the manufacture website for recalls.

Diabetics rely on important devices like Medtronic’s insulin sets and insulin pumps to keep their blood-sugar levels in check. As the manufacturer, Medtronic has a responsibility to ensure their products are safe and reliable. If you have relied on a medical device but have suffered an injury or harm due to a defect, you could be eligible to recover financial compensation.

The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.
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First published by Admin on February 14, 2018
Posted in the following categories: Latest Medical Products Recalls and tagged with | |


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