Medical device company Medtronic has recalled two of its MiniMed insulin pumps over incorrect dosing.
Specifically, MiniMed 600 Series Insulin Pumps — Model 630G and Model 670G — have been recalled, totaling 322,005 devices.
The Food and Drug Administration has classified this a Class I recall — its most serious class of recall.
One death and 2,175 injuries have been reported to the FDA, which has received 26,421 complaints about the device malfunctioning. The issue stems from a missing or broken retainer ring. That fastener aids in securing the insulin cartridge into the pump's reservoir compartment. An unsecured cartridge can lead to too much or too little insulin delivered to the user. That can lead to low or high blood sugar levels. Severe cases of high blood sugar can cause people to have a seizure, lose consciousness or die.
The Model 630G pump can be used by ages 16 and older, while the Model 670G version can be used by ages 14 and over. The former has been in distribution from September 2016 to October 2019, ands the latter was distributed from June 2017 to August 2019. The recall is for all 630G pumps distributed before October 2019 and 670G pumps distributed before August 2019.
Medtronic notified affected customers in November 2019. Among the advice was to check the retainer ring of the pump, including if the pump is dropped, examining again for damage. If damaged or the reservoir doesn’t lock into the pump, customers should stop using the pump and follow doctor’s recommendations. Manual insulin injections should occur.
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