Australian Health Regulators Issue Three Medtronic Insulin Pump Warnings

Australian health regulators just issued three safety advisories over potential issues with some of Medtronic’s Paradigm insulin pumps.

The Australian Therapeutics Goods Administration (TGA) issued the warning to patients, indicating that while the issues are rare and may not necessitate device replacement, some Paradigm Insulin Pump models may exhibit loose drive support caps, which can be more pronounced if the device hits a hard surface, said Mass Device especially if the device hits a hard surface.

The support cap holds the device’s motor, which aids in the delivery of insulin, in place. The TGA said that Medtronic sent warnings to health care providers, urging them to ensure patients are aware of the potential issues and how to avoid them, said MassDevice.

The Australian regulators said that they were told of at least one patient who was accidentally injected with a dose of insulin when an attempt was made to place the loose cap in place, said Mass Device. The injection caused severe hypoglycemia, the report noted.

The second issue involves the pumps exhibiting a “sensor graph timeout,” in which the insulin pump is prevented from automatically resuming its basal delivery.

Authorities also warned that water exposure may damage the pump’s internal electronics and that, said the advisory, the Paradigm are “designed to withstand splashing or brief dunking, but should not be immersed in water,” MassDevice wrote.

Earlier this month, Animas 2020 insulin pump devices were recalled over a defect that might put patients diagnosed with diabetes at risk. Animas is Johnson & Johnson’s insulin pump unit.

The Animus 2020 insulin pump’s defect may result in unintended insulin delivery, leading the U.S. Food and Drug Administration (FDA) to deem Johnson & Johnson’s move a Class I recall. A Class I is the agency’s most serious designation and indicates that use of the recalled device could lead to serious injury, even death.

The defect may also prompt patients to rewind, load, and prime the Animus insulin pump device, which may lead to an unnecessary infusion of medicine, placing patients at increased risks for hypoglycemia. The pumps were also constructed with a software defect in which they become unusable as of December 21, 2015, said Animas. Animas did not indicate if any adverse event reports related to the device’s defect have been received. The FDA advises consumers to report issues with the recalled Animas insulin pump through its online MedWatch system, according to the Fierce Medical Devices report.

This entry was posted in Defective Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.