Medtronic (NYSE:MDT) is informing customers with a select number of its MiniMed 620G and 640G insulin pumps of an issue with the Bolus screen displaying a bolus amount that is not up to date, according to an FDA report filed last week.
Medtronic began notifying customers with the devices on June 19, informing them of an error with the Bolus wizard in which the screen will not time out and end up displaying the wrong bolus amount, according to the FDA filing.
The letter advised patients to not activate insulin delivery on any bolus based on a blood glucose value that is more than 12 minutes old.
“When using the MiniMed 640G insulin pump, there are certain scenarios where the pump message screens will not timeout, which could cause confusion. Therefore, we have updated the user guide with instructions about responding promptly to pump screen messages. An updated copy of this user guide is being sent to customers who have a MiniMed 640G. We thank our customers for continuing to put their trust in us and encourage anyone with questions to contact their healthcare professional,” a Medtronic spokesperson told MassDevice.com.
No products need to be returned to the company as a result of this notification, the spokesperson added.
1936 units are affected by the possible glitch, distributed to Australia, the Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden and the United Kingdom.
No cause for the error has been determined, but Medtronic is investigating the issue, according to the FDA filing.
Medtronic launched the MiniMed 640G globally in January. The pump uses Medtronic’s “SmartGuard” technology, designed to suspend insulin delivery when it senses that the patient’s glucose levels are headed toward a low limit, then resume delivery once glucose levels recover, according to a press release.
Updated with new information from Medtronic, and a correction to the article which referred to the patient notification as a recall.