Huh. The link below is to the Australian Government Department of Health’s Therapeutic Goods Administration (TGA). (Yep. That’s apparently the actual title of the agency. 
)
MiniMed 640G: Recall for product correction — potential for user error leading to incorrect dosing
My understanding of it is that the problem is not that the pump delivery would malfunction so much as the user may be mislead to choose to bolus an incorrect amount of insulin. Apparently the pump is not “timing out” in all cases when the a bolus wizard is used (I think)?
Goggle also turned up the blog entry on the site insuilnnation.com linked below.
“Flaw Detected in Medtronic MiniMed 640G”, July 29th, 2015
Apparently the US FDA has also issued a notice about this. As the blog entry above notes, this is rather unexpected since the FDA usually doesn’t issue notices about medical devices which are only sold in other countries outside the US.
Huh.
Huh - thanks for sharing this information!
The FDA has not actually issued a notice. They do have a MAUDE - Manufacturer and User Facility Device Experience event report but it does not describe that problem. Here is what I found:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4909224
Medtronic does not have any alert notice on their Product and Safety Notice alert page.
Which non-US Medtronic sites did you look at?
Just the one you linked. I should have said “Medtronic does not have any alert notice on their Product and Safety Notice alert page in the USA,” Also I noted that the recall is voluntary
Here is the letter sent to 640g customers and it says “This is not a product recall, but only an update to IFU and no product needs to be returned.”
When I searched for 640G on the FDA site you linked to, I found this recall listed as an “Enforcement Report” entry. (Whatever the heck that is …)
The thing is that the pump is NOT recalled at all. The user guide is being updated, and this whole thing is to let folks who have that pump this necessary information. This is copied from the letter sent to customers:
***The purpose of this letter is to inform you that when using the MiniMed 640G insulin pump, there are certain scenarios where the pump message screens will not timeout, which could cause confusion and may potentially result in over or under delivery of insulin. Therefore, we have updated our user guide which includes the updates outlined below. Enclosed you will find a copy of the updated user guide for your use. Please dispose of the previous version of the user guide.***… and so on.
I was just hoping to let any users of this pump that the pump is not recalled for product correction, the user guide is revised.
That is the language the Therapeutic Goods Administration used, not me. I just quoted them.
I suspect that it’s because IOB, as calculated by a pump, is totally SWAGging. If you put in 3 hours duration vs. 4 or 5 or 6 hours duration of insulin action, you’ll get different answers down the road as far as how much insulin is actually cooking away on board in your system. I don’t totally think that it’s something to freak out about as, after you practice with the gizmo for a while, you’ll notice if there’s something off, like no IOB or other inputs and crashing, maybe your duration is too short as perhaps IOB is causing the crash? Or, vice versa, you have a long duration but your BG goes down early, due to a concentration of IOB. Perhaps a shorter duration will more closely match reality? But it probably won’t hit it with any degree of precision. It’s sort of area bombing…
