INSULIN PUMPS

KEY POINTS

• There are an estimated 451 million people living with diabetes worldwide.¹ In the U.S., more than 30 million Americans — or more than 9% of the population — have diabetes, which includes 1.25 million children and adults who have type 1 diabetes. Diabetes remains the seventh leading cause of death globally.
• Insulin pumps are sophisticated medical systems used to deliver insulin to patients with diabetes who do not have the ability to produce it naturally. The pump delivers insulin in a manner that, as closely as possible, mimics the function of a healthy human pancreas with the goal of normalizing blood glucose levels as much as possible.
• For more than 35 years, Medtronic and its subsidiary MiniMed have been committed to helping people with diabetes achieve better clinical and quality of life outcomes — beginning with the introduction of the MiniMed 502 insulin pump and now with the world’s first hybrid closed loop system.
• The comprehensive and rigorous body of clinical trial and real-world data strongly supports both the safety and efficacy of our insulin pumps, which have benefitted 1.2 million patients over the last four decades.
• Medtronic takes adverse event reporting very seriously and investigates them thoroughly.

Overview

1. Diabetes Affects More Than 451 Million People Worldwide and Is the 7th Leading Cause of Death
   
   

   There are an estimated 451 million people living with diabetes worldwide.¹ In the U.S., more than 30 million Americans — or more than 9% of the population — have diabetes, which includes 1.25 million children and adults who have type 1 diabetes. Diabetes remains the seventh leading cause of death globally. In the United States alone, there are 79,535 death certificates listing diabetes as the underlying cause of death, and a total of 252,806 death certificates listing diabetes as an underlying or contributing cause of death.² In the U.S., it is estimated that one in eleven people will have diabetes by 2045.³

   The complications stemming from high and low blood sugar levels can lead to serious short- and long- term complications including kidney failure, blindness, nerve damage, heart attack, stroke, and pregnancy complications. Low blood sugar levels (hypoglycemia) can be life-threatening, particularly at night when they are most difficult to manage. Type 1 diabetes is associated with an estimated loss of life-expectancy of up to 13 years.⁴

2. Medtronic’s MiniMed Insulin Pumps
   
   

   For more than 35 years, Medtronic and its subsidiary MiniMed have been committed to helping people with diabetes achieve better clinical and quality of life outcomes — since the introduction of the MiniMed 502 insulin pump and subsequent innovations leading up to our latest hybrid closed loop advancement.

   These innovations include products to further improve diabetes management, including soft flexible cannulas to improve patient comfort, continuous glucose monitoring systems to improve blood glucose control, and advanced software to help people with diabetes avoid hyper- and hypo-glycemic episodes. Large scale studies conducted over the last 15 years have shown that our insulin pump technologies significantly improve diabetes management.

3. Robust Clinical Data Indicates Medtronic’s MiniMed Insulin Pumps Are Safe
   
   

   In evaluating and monitoring the safety of our products, Medtronic carefully considers the totality of available scientific evidence, with emphasis on data from controlled clinical trials and studies conducted under real-world conditions. The totality of that data strongly supports both the safety and efficacy of our insulin pumps, which have benefitted over 1.2 million patients over the past four decades.

4. Inaccurate and Misleading Media Claims Regarding Insulin Pump Adverse Event Reports
   
   

   Recent media stories suggest, based on analyses of adverse event reports from the Manufacturer and Used Facility Device Experience (MAUDE) database, that insulin pumps have more problems than any other medical devices on the market. These reports have also linked insulin pumps to numerous injuries and deaths. These stories are inaccurate and highly misleading. As the FDA has recognized, adverse events reports “cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices” and that “the number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.”⁴

   That is because adverse event reports have significant and well-established limitations. As a threshold matter, the fact that an adverse event is reported regarding a certain device does not mean that the device malfunctioned or that the event is attributable to the device. Indeed, to be considered an “adverse event,” only the barest information is required. For medical devices, all that is needed is an allegation of an injury involving a device. Further, adverse event reports may be voluntarily filed by individuals with no medical training (e.g., patients, family members, or lawyers) and may contain limited or incomplete information. Additionally, adverse event reports also can be duplicative and occasionally affected by external factors such as media reports or litigation.

   With regard to insulin pumps specifically, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) analyzed insulin pump adverse event reports from the FDA’s MAUDE database – the same adverse event database relied on in the media reports – and concluded that “the majority of reports are submitted by users” and that “the majority of [insulin pump adverse events] relate to human factors/user error rather than to technical pump malfunctions….”⁵

   For more information regarding the misleading news coverage pertaining to Medtronic medical device adverse events, please see our November 28, 2018 Statement Regarding News Coverage Pertaining to Medtronic Medical Device Adverse Events.⁶

See also:

• Safe and Responsible Product Development
• Responsible Promotion and Compliance
• Medical Device Labeling
• Medical Device Regulations
• Medical Device Adverse Events Statement