The FDA has announced a class I recall (the most serious kind) for Medtronic MiniMed insulin pumps used by thousands of people with type 1 diabetes after more than 2,000 were injured by the device and one person died. The FDA has received more than 26,000 complaints about the devices.
The recall applies to about 322,000 Medtronic MiniMed 600 series insulin pumps. The pumps may have a missing or broken retainer ring that does not lock the insulin cartridges into the reservoir compartment properly, causing them to deliver incorrect doses of insulin to diabetic patients, resulting in severe medical complications and even, in extreme cases, death.
Model 630G (MMT-1715) of the MiniMed 600 Series Insulin Pump is one of two models being recalled. All lots of this model distributed between September 2016 and October 2019 are being recalled. The other model is 670G (MMT-1780), and the recall applies to all lots distributed between June 2017 and August 2019. These devices are approved for use in type 1 diabetics above the ages of 16 and 14, respectively.
Medtronic informed affected users of the issue on November 21, 2019. “At Medtronic, patient safety is our top priority, and we are committed to delivering safe and effective therapies of the highest quality and reliability possible. We appreciate your time and attention in reading this important notification,” the letter said.
Anyone who owns or uses a Mini-Med insulin pump and has not received this letter, however, may call Medtronic or a doctor or pharmacist to find out whether their specific device is at risk. If you believe you have received an improper dose of insulin due to a faulty insulin pump, seek medical advice immediately.
You may also inspect your device to help determine whether it is working properly. Medtronic customers whose insulin pumps are working properly are advised to continue using them but to continue checking for damage at every set change or if the device is dropped or otherwise damaged. If the retainer ring is broken, loose, or missing, or if the reservoir does not lock into the pump correctly, discontinue use of the device and follow your doctor’s orders to perform manual insulin injections until you receive a replacement.
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If your insulin pump is not working properly, Medtronic will replace the device. Call the 24-hour Medtronic Technical Support line at 877-585-0166 to learn more. However, while you wait for the new one, you’ll have to do insulin injections by hand.
There’s no way to make sure medical devices like insulin pumps are completely safe from incidents like this, so, regardless of whether or not your specific pump was recalled, you should always take steps to ensure that you stay safe. Make sure you and your family members and other people close to you know the symptoms of hyperglycemia and hypoglycemia and what to do if it happens. Take good care of your pump and check regularly that it seems to be in good working condition. And when in doubt, opt to inject insulin manually rather than risk using a faulty insulin pump.Whizzco