Medtronic and the Food and Drug Administration (FDA) recently issued warnings to thousands of customers using Medtronic’s MiniMed 600 Series insulin pumps because the pumps may be incorrectly dosing insulin.
Due to a dangerous design flaw that has already left one person dead, Medtronic and the Food and Drug Administration (FDA) have issued a Class I recall of Medtronic’s MiniMed 600 Series Insulin Pumps. A Class I recall is the most serious type of recall and, according to the FDA, “means that use of such products could result in serious injury or death.” The recall was issued because the insulin pumps “may be incorrectly dosing insulin.” This is a serious problem because when a pump delivers too much or too little insulin it could “cause life-threatening complications in people with Type 1 diabetes.”
The specific pumps affected by the recall include Medtronic MiniMed Models 630G/MMT-1715 distributed from September to October 2019 and 670G/MMT-1770 distributed from June 2017 to August 2019. According to the recall notice, the flaw is “due to faulty retainer rings on the pumps, which can lead to incorrect dosing.” Already the company has received about 26,421 customer complaints about the rings. To make matters worse, the faulty rings have caused 2,175 injuries and one death so far, according to the FDA.
Medtronic and the FDA didn’t discover the issue just yesterday, though. In fact, Medtronic has known about the design flaw for months and notified customers about potential issues with the pumps back in November. In letters sent to customers, the company advised users to “check the retainer rings on their pumps and said that if the reservoir compartment is not locking onto the pump or if the ring is loose, damaged or missing, they should stop using the pump immediately and contact their doctor to switch to another way to administer insulin.”
According to Medtronic, if a customer’s “reservoir is locking into place correctly, they can continue to use their pump.” The company also noted that customers should check to make sure the reservoir is locked currently after every chance. Additionally, the “pump should not be used if the reservoir or the ring are damaged.” For now, customers who have a faulty retainer ring can contact Medtronic customer service at 877-585-0166 or the website for a replacement pump.