Over 300,000 insulin pumps recalled for incorrect dosing issue

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WASHINGTON, D.C. (WTHR) - More than 300,000 insulin pumps have been recalled because they may not be providing the correct amount of insulin.

The FDA says over 320,000 MiniMed 600 Series Insulin Pumps produced by Medtronic are being recalled. The affected devices include the Model 630G distributed between September 2016 and October 2019 and the Model 670G distributed between June 2017 and August 2019.

The affected pumps, used by patients with Type 1 diabetes, could have a missing or broken retainer ring, which helps lock the insulin cartridge in place. When the cartridge is not properly locked in, an over- or under-delivery of insulin. That could result in hypoglycemia or hyperglycemia.

The FDA says a severe case of hyperglycemia can result in a loss of consciousness, seizure and death. At least 2,175 people have been injured by the affected products and one person has reportedly died.

Medtronic sent a letter to customers explaining the issue with the pumps.

Here's what to look for if you're using one of the affected models of MiniMed Insulin Pumps:

  • Examine the retainer ring of their pump.
  • Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing. If you stop using the pump, you should follow your doctor's recommendations and perform manual insulin injections.
  • Continue using the pump if the reservoir locks in place correctly.
  • If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.
  • Check the pump retainer ring and verify that the reservoir is locked correctly at every set change.

Customers with questions about the product or recall can call Medtronic at 877-585-0166.

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