FDA warns of security risks in certain Medtronic insulin pumps

There’s a good deal of overlap with the pumps that are compatible with Loop. Here’s the Loop list:

Here’s the FDA warning list:

I wonder what the real backstory is here.

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I’m using Omnipod and turning my Ping in for the $750 gift card Animas is providing. But I have a 723 that will now be my only spare pump. Not likely but it is possible to one day run out of pods. Or something. I wish there was a way to trade in the 723 ( warranty is up Fall 2021) and just not proceed with training yet on a new Medtronic. It would be nice to have something set aside for emergency.

Terry4, I suspect that Medtronics is trying to clear the marketplace of pumps that can be looped.

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Exactly!

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Which makes me also suspect that the Animas Ping with its remote capability will also be looped eventually. That is why Medtronics, under the guise of Animas, is offering $750 for the return of all those still under warranty. Why else?

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If warranty till 2021, you probably have a newer model than those listed (2.4). My warranty is up next year, and my version is 3.0, so does not qualify.

And a reminder from Animas in the mail today:

As you are aware, Animas is exiting the pump market. It is necessary that you make a change to your pump provider now. We have partnered with Medtronic to make the transition as smooth and simple as possible.

Animas Supplies Ending
Animas pump supplies will not be available from Animas or Medtronic after September 30, 2019. This includes cartridges, infusion sets, cartridge caps, battery caps and other accessories for Animas pumps.

Animas Exchange Program Ending
If your Animas pump is in-warranty, you are eligible to exchange it for the Minimed 630G or the Minimed 670G pump at no cost to you through the Animas exchange program. This program ends September 30, 2019.

Act Now - Time is Running Out

The same thought crossed my mind, too. But it’s curious that Med-T has known about their pumps being utilized in the do-it-yourslef systems for many years now and yet, at this late date, are taking this action.

The other motive that comes to mind is that they want to minimize any legal exposure that they may feel about their older pumps being used in DIY systems.

I don’t think that many (if any) people who already are using Loop, OpenAPS, or AndroidAPS will heed this Medtronic warning.

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It’s up in 2020 April. Where is the version? I’d best collect my $750 and then deal with them later I suppose.

On the bottom of system status screen, and may also be on back label.

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I wouldn’t be surprised if Medtronics has installed and played with the DYI solution.

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I totally agree @Terry4 - I think MDT is using this to target Loop and OpenAPS users.

This way, MDT can say, “Hey, we totally support what you’re doing here. Look we even signed onto the Tidepool Open protocol concept. It’s the FDA that’s forcing us to recall these dangerous pumps.”

My concern is will Medicare allow me to fill scripts for pumps that are on the list?

When I became Medicare-eligible in April, Edgepark was required (by Medicare) to get my pump model (522) and s/n.

As an aside, I keep hoping that ordering my supplies will get easier and more understandable as I get more experienced with being on Medicare, but I don’t have a warm and fuzzy feeling yet.

Most, if not all, of the pumps impacted are out of warranty. Most who had them got newer medtronic pump or switched to different brand. Old pump is either saved as backup, discarded, or potentially sold or given to looper.
If medtronic contacts me regarding my old 522 Pump, they would not replace it due to recall, since it is out of warranty, and I have a current in warranty pump, not recalled. And if they ask, I tell them I have no idea where my 2010 522 pump is.

I think Medtronic will do a “recall”, but few if any pumps would be returned. (Unless they offer cash for out of warranty pump).

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Or reverted to when much ballyhooed new hybrid closed-loop pump turned out to suck and the old pager style thing was actually less aggravating to use as a manual pump than the bells-and-whistles version, yeah. Now if only there were a way to revert to the loop-able software version…

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This is clearly the one and only motive and reason behind the Med “urgent field safety notification”. The number of people using DIY systems has grown to the point when DIY systems can no longer be ignored by Med, FDA or other players. But, they do not want to have anything to do with DIY systems, and the super-old-turned-urgent notification is just a convenient way for Medtronic to mitigate any legal responsibilities.

I do not know about you, but I am seriously concerned by the cybersecurity issues :wink:

More seriously, the “cybersecurity” term in the title of the notification is absurdly misleading, and is just meant to catch attention of the public, health-care providers, and news media.

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Don’t you know these systems are ALREADY BEING HACKED!?!?

Y’know, by DIY loopers like yourself. I suspect that’s the hacking they’re most concerned with, yup. Still, panic is our only option! Get rid of that thing and buy yourself a shiny new 670G before it’s too late!!!

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1126

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Not many security details were revealed.
My trust is less than I can spit a watermelon seed when there appear to be ulterior motives all “In The Name Of Security”.

I would question if there is ANY security risk AT ALL if the serial number of your pump is simply kept private and only shared with Tech Support. I suspect NOT.

IMHO ******** like this makes REAL security issues to be mostly ignored. The whole “Cry Wolf” thing…

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I’m surprised that the FDA used the “cybersecurity” term. It seems hyperbolic to me, especially since these pumps are not connected to the internet. It would make more sense if Medtronic mentioned this in their press release, but they did not. I would think that a regulator, like the FDA, would be try to restrain itself in its communication. I agree that the use of this loaded term is misleading.

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