FDA Warns of Insulin Dose Errors with Medtronic Pump Tubing July, 2013
The US Food and Drug Administration (FDA) recently issued a safety alert and Class I recall concerning the MiniMed Paradigm insulin pump from Medtronic.On June 7, 2013, Medtronic sent an urgent medical device safety notification to healthcare professionals to inform them of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors.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 hyperglycemia, which can be severe and lead to serious illness.
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 FDA alert reiterated advice from Medtronic that patients should watch for anything unusual during the process of priming the infusion set, such as insulin continuing to drip from the canula tip after priming is complete. This continued seepage may signify that the vents of the tubing connector are not working properly.
More information on this announcement, including model numbers, is available on the FDA website. Medtronic issued a statement published in 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.