Medtronic Insulin Pump Update 2018: FDA Expands Approval

It has been nearly a year since certain Medtronic Insulin Pump infusion sets were recalled by the device’s manufacturer after users experienced complications.

In September 2017, Medtronic announced a recall of certain infusion sets used with its insulin pumps. The recall was issued because of concern over a component linked to potentially deadly consequences for users of the pumps.

According to the recall, the vent membrane on some of the infusion sets could get blocked and create conditions in which too much insulin would be delivered to the user. Too much insulin can result in hypoglycemia or low blood sugar, which left untreated, can lead to death.

Medtronic said it discontinued the vent membranes in question, but provided no information as to how many sets were affected by the recall.

Risks of the Medtronic Quick-Set Infusion

When an infusion pump malfunctions, it can cause the user to suffer acute hypoglycemia, a severe and potentially fatal medical condition. In September of 2017, a voluntary recall was issued by Medtronic regarding its MiniMed Infusion Sets, which involved products used with all of its insulin pump models.

According to manufacturer, the cover over the vent of the infusion device can be affected by a blockage or become clogged during the filling of the infusion tube or during the priming of the tube. This typically happens after a change of device, and most frequently as liquid spills onto the insulin reservoir.

When this happens the meter can misread the need for an immediate insulin dosage and deliver too much dosage, putting users at risk for hypoglycemia.

Problems with the Medtronic pump can cause a number of side effects, including:

• Rapid heartbeat
• Trembling or shaking
• Sweat
• Blurred or double vision
• Headaches
• Confusion
• Moodiness, primarily anger or anxiety
• Fatigue or inability to stay sleep
• Pale or tingling skin
• Fainting
• Seizure
• Coma

The infusion sets affected by the problem were replaced by new sets that hit the market in April 2017. The new design features an updated design of a membrane that should reduce the risk for over-delivery of insulin. Medtronic has encouraged users of its insulin pump to use only the updated infusion sets.

Users of Medtronic insulin pumps can check the Medtronic website and use the lot look-up tool to see if any of the infusion sets they have were affected by the recall.

FDA Expands Approval for Usage of Medtronic Insulin Pump for Pediatric Patients

Despite problems with the Medtronic insulin pump infusion set, the company recently announced expansion of use for its pump systems.

Just recently, Medtronic received approval from the US Food and Drug Administration (FDA) for the expanded use of its MiniMed 670G hybrid closed loop system to younger patients aged 7 to 13. The device automatically monitors glucose levels and provides insulin without action from the user.

In September, shortly after the recall, the FDA approved the device for use by patients ages 14 and up.

As a result of the complications that arose from use of the faulty infusion sets, a number of lawsuits have surfaced against Medtronic.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.