Medtronic ($MDT) must deal with an Australian safety advisory concerning some potential problems with its Paradigm insulin pumps.
The Therapeutics Goods Administration's advisory covers three possible issues. Regulators warn that some Paradigm models may have a loose drive support cap (which holds the pump motor in place). Sensor graph time-outs are also flagged as a potential issue. Additionally, regulators warn of possible water damage to the pump's internal electronics if it is immersed in water for too long (it can withstand splashing or brief dunking, however).
Nine Paradigm model numbers are named in the advisory, though the TGA notes that the issues are considered "rare." But the mechanical issues could cause patients harm. Consider the drive support cap issue, which is particularly important, because it holds the pump motor in place, which is crucial to driving the insulin delivery. The TGA mentioned for example, that one patient tried to push the drive support cap in place, while still attached to the pump. As a result, the patient dealt with an unexpected burst of insulin from the pump, and developed severe hypoglycemia.
Medtronic wrote providers who have patients with the affected pump and notified them about the potential issues, and also wrote affected inulin pump patients and gave them a series of instructions about how to proceed if the aforementioned problems take place.
Medtronic's insulin pump business generally has buzzed along quietly without much fanfare. Last year in the U.S., at least, Medtronic was involved in discussions about how to prevent computer hacking of insulin pumps.
- read the full alert
- here's MassDevice's take