FDA Warns of Insulin Dose Errors With Medtronic Pump Tubing


July 12, 2013

Patients with diabetes using the MiniMed Paradigm insulin pump from Medtronic should be aware of the potential for a dosing error if insulin or another fluid contacts the inside of a tubing connector, the US Food and Drug Administration (FDA) announced today in a MedWatch safety alert.

Insulin from the pump unit travels through disposable tubing called an infusion set and enters the body through a soft cannula.

On June 7, Medtronic notified both users and clinicians about the possible consequences of insulin or some other liquid coming into contact with a component that connects the infusion set with a reservoir of insulin inside the pump unit. When that contact occurs, the insulin can temporarily clog up the vents in the tubing connector that permit the pump to properly prime itself. Vent blockage can cause too little or too much insulin to be delivered, possibly triggering either hypoglycemia or hypergylcemia. Extreme cases of either condition may lead to unconsciousness and death, Medtronic said.

The company notification explained to patients and clinicians how to avoid getting the inside of the tubing connector wet. If either the tubing connector or the end of the insulin reservoir becomes wet, patients should start over with a new reservoir and infusion set.

The MedWatch alert issued by the FDA reiterated another piece of advice found in the company notification. Patients should watch for anything unusual during the process of priming the infusion set, such as insulin continuing to drip from the cannula tip after priming is complete. This continued seepage may signify that the vents of the tubing connector are not working properly. In that event, patients should not insert the cannula but instead call a company helpline (1-888-204-7616).

Today's alert is classified as a Class I recall. However, Medtronic company spokesperson Amanda Sheldon told Medscape Medical News that customers do not need to return the MiniMed Paradigm infusion sets because they will work as intended if pump instructions are followed.

Hundreds of thousands of patients with diabetes worldwide use the MiniMed Paradigm insulin pump, said Sheldon, but she did not supply a more exact number except to say that it was under 500,000.

More information on today's announcement, including model numbers, is available on the FDA Web site.

To report problems with MiniMed Paradigm infusion sets, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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