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The FDA on Wednesday said it has identified Medtronic's decision to withdraw its MiniMed 600 series insulin pumps for incorrect dosing as a Class I recall, after the company received over 26,400 complaints related to the devices having malfunctioned in this way, and is aware of 2175 injuries and one death. The US regulator noted that 322,005 devices have been pulled from the US market since Medtronic first notified customers about the issue last November 21.
The action applies to all lots of MiniMed model 630G before October 2019 and of model 670G before August 2019. Medtronic is recalling the devices due to a missing or broken retainer ring that helps to lock the insulin cartridge into place in the pump's reservoir compartment. "If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycaemia or hyperglycaemia," the FDA said.
Medtronic launched the MiniMed 630G system with SmartGuard technology in the US in 2016 for the treatment of patients with diabetes aged 16 years and older. The FDA approved the MiniMed 670G hybrid closed-looped system soon after for patients with type 1 diabetes aged 14 years and older, with the device launched the following year. In 2018, the regulator expanded approval of MiniMed 670G system to include patients as young as seven years of age.
In June last year, the FDA issued a warning about some other MiniMed insulin pumps that were vulnerable to possible cyber attacks. The recall included Medtronic's MiniMed 508 and MiniMed Paradigm series insulin pumps, which were believed to be used by potentially 4000 US patients.
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