By James Crowley
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Health care technology company Medtronic recalled more than 300 thousand MiniMed 600 Series insulin pumps Wednesday in a Class I recall after thousands of injuries and one death.
Medtronic recalled all Model 630G pumps from before October 2019 and all Model 670G pumps from before August 2019, according to the FDA. The model numbers for the pumps are MMT-1715 and MMT-1780, respectively. These devices may be used by people who have Type 1 diabetes to administer insulin. The 630G model may be used by people age 16 and older. The 670G model may be used by people 14 years old and older. Besides people with diabetes who use the pump, this may affect health care providers who treat people with diabetes using this pump.
According to the FDA, the affected pumps have a broken or missing retainer ring, which locks the insulin cartridge in the pump's reservoir compartment. This can cause the under- or over-delivery of insulin if the cartridge is not securely locked in place. Hypoglycemia or hyperglycemia can occur in these instances. Severe hyperglycemia can lead to loss of consciousness, seizure or death.
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The FDA identifies a Class I recall as the most serious, where exposure to the product may result in death or adverse health consequences. Medtronic received 26, 421 complaints where the device malfunctioned and is aware of 2,175 injuries in addition to the death.
On November 21, 2019, Medtronic advised customers to examine the retainer ring on their pump through a safety notification. Officials said that if the cartridge doesn't lock or the retainer ring is loose, damaged or missing, customers should stop using the pump and contact Medtronic for a replacement pump. If the pump is dropped, check to see if the retainer ring is damaged and stop using the pump if it is. They also advise checking the retainer ring and ensure that the reservoir is locked correctly at every set change.
If the reservoir locks in place correctly, customers may continue to use their pump, Medtronic officials said.
Customers who would like more information about this recall or have questions can call Medtronic's 24-hour Medtronic Technical Support at 877-585-0166.
In an FAQ for the safety notification sent out for the products, Medtronic noted that this recall does not apply to the MiniMed Paradigm insulin pumps.
"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," MedTronic wrote in the November safety notification.
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