MASSDEVICE ON CALL — Healthcare regulators down under issues a safety advisory for a trio of potential problems with certain Medtronic’s (NYSE:MDT) Paradigm insulin pumps.
The Australian Therapeutics Goods Admin. warned patients of 3 issues, but noted that "these issues are rare and it is unlikely that you will need to replace your Medtronic Paradigm Insulin Pump."
Certain models of the insulin pumps may exhibit loose drive support caps, especially if the device hits a hard surface. The support cap holds the device’s motor in place and helps deliver insulin.
Regulators have received word of at least 1 patient who attempted to put the loose cap back in place and accidentally injected a dose of insulin, resulting in severe hypoglycemia, according to the report.
The devices may also exhibit a "sensor graph timeout," which may prevent the insulin pump from automatically resuming its basal delivery.
Finally, the authorities warned that exposure to water may damage the pump’s internal electronics. The Paradigm pumps are "designed to withstand splashing or brief dunking, but should not be immersed in water," according to the advisory.
Medtronic sent warnings to healthcare providers, advising them to make sure patients are informed about the potential issues and how to circumvent them, the TGA said.
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