In July 2019, the U.S. Food and Drug Administration (FDA) issued alerts on Medtronic’s 600-series MiniMed insulin pumps.
It appears that when air pressure changes quickly, such as during take-off or landing, the device’s keypad buttons could temporarily become “unresponsive”.
This means that users may not be able to program a bolus or suspend delivery, since the buttons won’t temporarily press down. However, the basal insulin continues to be delivered.
The good news is that in most cases, when atmospheric pressures normalizes, the buttons will work again in about thirty minutes. Also, pump users can resolve the issue by taking off the battery cap and putting it back on again.
Medtronic is actively working on a long-term hardware solution for this rare situation.
The alerts, classified as a class II recall by the FDA, apply to the MiniMed 620G, 630G, 640G and 670G models. A class II recall is considered medium severity and is used when the probability of a serious adverse consequence is considered remote. The FDA and Medtronic are not requesting any devices be returned, they are just making sure Medtronic pump wearers are aware of this issue.
Read the complete article here.
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