Medtronic Recalls Insulin Pumps Increasing the Risk of Incorrect Dosing

Medtronic, a medical device firm, is recalling some kinds of insulin pumps because it has just detected a dangerous defect that would have a negative effect on around 320,000 customers with diabetes type 1.

The Food and Drug Administration (FDA) considered this recall of MiniMed 600 Series to be in the “Class I”, which is the most serious form of recall in the United States. This means that severe injuries or even death would occur when customers keep using these products.

Insulin pumps are basically products that are manufactured to provide precise insulin dosages, depending on the blood sugar levels of the patient. Those devices that are being recalled might dose insulin incorrectly. In general, providing too little or too much insulin would lead to life-threatening issues in patients with diabetes type 1.

According to the announcement of the FDA, the problem is caused by defective retainer rings on these insulin pumps, which would result in wrong dosing. Medtronic has received more than 26,400 complaints about these components, leading to 1 death and around 2,170 injuries. The list of pumps affected includes two types: 670G/MMT-1770 (available from 06.2017 to 08.2019) and 630G/MMT-1715 (available from 09.2019 to 10.2019).

Medtronic first warned its customers about possible issues with these insulin pumps in November last year. In the alerts, the company suggested patients examine the retainer rings. If the reservoir compartments do not lock on the pump or if the rings are missing, damaged, or loose, they should immediately stop using these pumps and look for another option for administering insulin from their healthcare provider.

If the reservoir of these insulin pumps still locks into place properly, the consumers would still use them as usual. It is important to check this condition after each change, particularly when the reservoirs are dropped. Also, the pumps should not be used when the ring or the reservoir is damaged.

According to the alerts from Medtronic, a patient can contact the company’s customer service to replace the pump when he or she finds out a defective retainer ring. This can be done via the official site or the support line at 877 – 585 – 0166.

This is actually the second recall of insulin pumps from Medtronic over the last year. The firm had the first one in August due to cybersecurity risks associated with the remote controllers of several devices. The Paradigm model and 500 series remotes were found out to be susceptible to hacking problems one month earlier.

Source:

https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-minimed-insulin-pumps-incorrect-insulin-dosing

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