FDA Announces Recall of Medtronic MiniMed Insulin Pumps in Use in Europe

The Food and Drug Administration (FDA) has announced the recall of nearly two thousand Medtronic MiniMed 640G insulin pumps in use in Europe and Australia because of difficulties with a screen not properly timing out.

This insulin pump model was launched in Europe in January and the affected pumps were distributed in10 European countries and Australia, according to the recall notice just issued by the FDA. Medtronic plans to submit an FDA premarket approval application for the MiniMed later this year, FierceMedicalDevices reports.

The problem reported with the MiniMed 640G pumps is that the system does not always time out when the screen is set for a bolus insulin delivery. This can cause confusion for patients because the bolus amount on the screen is no longer accurate. (A bolus dose of insulin is taken at mealtime to keep blood glucose levels under control following a meal.) The ability to suspend and then restart insulin delivery levels automatically based on sensor glucose levels is touted as the advantage of the MiniMed 640G. This pump is considered a step toward an artificial pancreas that can automatically regulate insulin for diabetics, according to FierceMedicalDevices.

The recall includes 1,936 pumps distributed in Australia, Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the United Kingdom. The recalled pumps are MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.

The FDA has categorized this as a Class 2 recall—the intermediate of the three device recall classes. Use of the affected device could cause reversible adverse health consequences. Though the device does not pose immediate risk of serious injury or death, those risks are still present and consumers should follow the FDA’s instructions for correcting the problem. Medtronic notified customers of the inaccurate bolus screen problem by letter on June 19. Medtronic has not asked that the pumps be returned, but the company advises MiniMed users to respond promptly to bolus screens and not to activate bolus insulin delivery based on a blood glucose value that is more than 12 minutes old. Medtronic has updated the MiniMed user guide. The letter informs customers of the summary of changes in the MiniMed 640G insulin pump user guides.

 

 

from Parker Waichman http://www.yourlawyer.com/blog/fda-announces-recall-of-medtronic-minimed-insulin-pumps-in-use-in-europe/