Medtronic is warning its customers that there has been a “higher than expected number of reported complaints” of its MiniMed Pro-set infusion sets. The surge in complaints stems from kinked cannulas that can interrupt the flow of insulin, leading to elevated blood sugar levels.
Read “Dexcom recalls G4 and G5 CGMs.”
Customers can return any unused MiniMed Pro-set infusion sets for either replacement Pro-set infusion sets or a different model of Medtronic infusion sets. It should be noted, however, that this is not an official FDA recall.
This infusion set issue was first reported by Diabetes Mine.
Those who don’t wish to replace their infusion sets can “minimize their risks” by following best practices for the product’s use, according to Medtronic. These include reviewing the online instructions and frequent monitoring of blood sugar levels. Another suggestion (which seems a bit cheeky in light of the issue) is to buy another Medtronic product, the MiniMed Quick-serter insertion device.
Read “Flaw Detected in Medtronic MiniMed 640G.”
This notice covers all MiniMed Pro-set infusion sets. These include:
Model Connector
MMT-280 MiniMed
MMT-281 MiniMed
MMT-290 Luer Lock
MMT-291 Luer Lock
To order replacement infusion sets, Medtronic suggests using this online form: https://www.medtronicdiabetes.com/notice5/affected-lots/form. You can also call 1-866-222-7304.
If you experience a problem with these infusion sets, you can report it to the FDA at http://www.fda.gov/safety/medwatch/howtoreport/default.htm. Reporting problems can help the FDA determine when a medical device recovery is necessary.
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