WHO.

Founded by a dedicated father & biomedical engineer, ThirstyDiabetic.com emerged from a deeply personal journey. Our commitment lies in helping families and individuals navigate the intricate world of medical devices and treatments, particularly those concerning T1D

WHAT.

At ThirstyDiabetic.com, we provide comprehensive, accessible, and up-to-date information about medical device safety and treatments. Originally focused on Type 1 Diabetes, we have expanded our scope to include all major classes of medical devices.

WHY.

We believe in the power of information, and that safety is paramount in managing health conditions. Our mission is to transform the experience of navigating healthcare treatments and medical devices, making it less daunting and more empowering for everyone involved.

Insulin Pump Reported Events

The graphs below don’t necessarily present the full picture and should not be consumed without the full understanding of how this data is collected and reported to the FDA.  However, it’s also unwise to select medical devices for our children without any sort of data around the safety therein. 

Learn. 

FDA MAUDE Data
Medtronic 
Insulin Pump

High-level data MAUDE data for the Medtronic insulin pump. As always, it’s important to look into at the details and to not rely solely on this high-level data. 

Learn.

FDA MAUDE Data
Omnipod 5
Insulin Pump

High-level data for the Insulet manufactured Omnipod 5. Please see our more comprehensive review for the Omnipod to inspect the underlying data. 

Learn.

FDA MAUDE Data
Tandem
Insulin Pump

Finally, the same timeframe of MAUDE Data for the Tandem insulin pump. Please scroll down this page to learn about FDA MAUDE Data. 

Latest Type 1 Articles and Blogs

Learn and Live.

In September 2020, the U.S. Food and Drug Administration (FDA) approved a drug called teplizumab (brand name: Otelixizumab) to slow down the progression of type 1 diabetes in people who have been recently diagnosed with the condition. Teplizumab is a monoclonal antibody that targets and blocks […]
Dr. Steve Edelman is a leading diabetes expert and endocrinologist who was diagnosed with type 1 diabetes at 15.  He has developed an approach to insulin therapy known as the “untethered insulin regimen.” This approach is based on using both an insulin pump and long-acting insulin […]
Beta cell replacement therapy is a promising treatment option for type 1 diabetes, but it is still in the early stages of development and is not yet widely available. The therapy aims to replace the insulin-producing beta cells that are lost in type 1 diabetes. This […]
While there is currently no cure for type 1 diabetes, there are several promising new treatments being developed that aim to improve the management of the condition. Some of the most promising new treatments include: Artificial pancreas: An artificial pancreas is a device that uses an […]
Diabetes: Best Practices after Diagnosis Best practices for newly diagnosed type 1 diabetics include: Learn as much as you can about the condition: Understanding the basics of diabetes and how it affects your body will help you manage your condition more effectively. Work with a diabetes […]
There have been reports of the charging cable for the new Omnipod 5 melting and possibly even catching fire.  As of this writing, there have been no reports of fire, but Insulet – the manufacturer of Omnipod – cautions this could pose a risk.

We want to build a community. Please join us.

Learn and Live.

Thirsty Diabetic is a
Family Effort

Raegan, our now 12 year-old daughter, bravely manages life with type 1 diabetes. She’s got the whole family behind her. That’s also Mt. Rainier behind us at Mirror Lake. If you’ve never visited the PNW, we highly recommend it. 

FDA MAUDE DATABASE 

Where Does Our Data Come From?

What is MAUDE?

The U.S. Food and Drug Administration (FDA) hosts a publicly available database of the acronym MAUDE – Manufacturer and User Device Experience.  

As with any data and analysis formed from it, the adage remains, “arbage in, garbage out.” MAUDE data is only as good as the data that’s shared with the FDA. 

Medical device companies, and other mandatory reporters are required to share medical device reports (MDR) with the FDA. While we agree with the FDA’s warning that no person should draw summary conclusions from the data, we also believe this data can provide diabetics and their families with information that can be included to from decisions regarding diabetic care. 

The detail below is important to consider and found on the MAUDE website here:

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters   1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.

Please see the   MDR Data Files webpage for Device Experience Network (DEN) and Alternative Summary Report (ASR) data received by the FDA.

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.

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.Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated.

MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions.

Variations in trade, product, and company names affect search results. Searches only retrieve records that contain the search term(s) provided by the requester.

Submission of a medical device report and the FDA’s release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.

Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by “(b)(4)”. If a report contains personnel or medical files information, that text is replaced by “(b)(6)”. The designations “(b)(4)” and “(b)(6)” refer to the exemptions in the FOIA. For example, “(b)(4)” may be found in place of the product’s composition and “(b)(6)” may be found in place of a patient’s age.

MAUDE is updated monthly and the search page reflects the date of the most recent update. The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed.