Australian health officials have issued three warnings over problems with Medtronic Paradigm Insulin Pumps, which has been linked to a number of issues in recent years in the U.S. as well.
The Therapeutic Goods Administration in Australia issued a safety advisory on April 10, highlighting three potential Medtronic Pardigm insulin pump problems that users may face. The agency regulates medical devices and drugs for Australia, and indicated that patients using the pumps will also soon receive a letter from Medtronic, the manufacturer.
According to the advisory, the three issues with the Medtronic insulin pumps include the risk of a loose support drive cap, sensor graph timeouts and water damage.
The support drive caps hold the pump’s motor in place. In some cases the cap could stick out from the bottom of the reservoir compartment, especially if the pump has been dropped or suffered a sharp impact. In one case, a user suffered severe hypoglycemia after trying to push the cap back into place, which caused the pump to unexpectedly deliver a dose of insulin.
Users who suspect they have a loose drive cap should not try to push the cap back into place, according to the agency. In such cases, consumers should stop using the pump, go to a back up diabetes management plan and contact their health care provider, as well as Medtronic.
The sensor graph timeout problem applies only to the Paradigm VEO pump using Medtronic Continuous Glucose Monitoring with the Low Glucose Suspend feature enabled. If the sensor graph timeout is set to “None” it could delay the auto-resume feature for basal delivery for two hours after a Low Glucose Suspend warning.
The agency warns that the device will beep three times every 15 minutes when this happens, but as long as the sensor graph screen is displayed, basal delivery has not resumed. Users are advised to avoid setting the sensor graph timeout to “None.” If they have already done that, they should reset Graph Time Out, selecting 2, 4 or 6 minutes.
Australian officials also say that water can damage the internal electronics of the Paradigm pump. While it is designed to undergo splashing or brief dunking without damage, it is not made to withstand full immersion.
The warning includes model numbers MMT-511, MMT-512, MMT-515, MMT-522, MMT-554, MMT-712, MMT-715, MMT-722, and MMT-754.
The Paradigm insulin pump and a number of other infusion sets by other manufacturers have had problems in recent years. In April 2010, the FDA launched an infusion pump safety initiative that requires manufacturers to undergo more risk assessments before gaining approval for new or modified devices.
In 2009, a recall was issued for Medtronic Paradigm insulin pump Quick Sets after the company determined that about 60,000 infusion sets used with the pumps were defective and could give too much insulin to users due to an air pressure problem.