New Warnings for Medtronic Paradigm Insulin Pump Problems

April 14, 2014 — Australian health authorities have issued yet another safety warning for the Medtronic Paradigm insulin pump because it can deliver too much insulin with the push of a button.

The Paradigm pump can deliver both continuous, minimal dose of insulin (basal) and larger doses when required (bolus). In certain modes, it can switch from zero to maximum with a single click.

Medtronic has received a number of reports of hypoglycemia (low blood-sugar) that occurred when patients accidentally pushed a button, causing the pump to deliver the maximum amount of insulin. At least one victim in Australia was hospitalized.

The U.S. Food and Drug Administration (FDA) has issued warnings about the Paradigm pump in the last. In July 2013, the FDA issued a Class 1 Recall for Paradigm Insulin pumps due to the risk of over-delivery or under-delivery of insulin.

The Australian Therapeutic Goods Administration (TGA) issued a Safety Advisory in April 2013 after discovering three potential but rare issues with the Medtronic Paradigm Insulin Pump. These problems included a loose drive support cap, sensor graph timeout, and water damage. In one case, a user tried to push the drive support cap back in place and accidentally delivered a large dose of insulin, causing hypoglycemia.

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