[Diabetes-Talk] [Tech-VI] t:connect iOS app for insulin pump could kill users, says FDA

Fri May 24 20:19:48 UTC 2024

Hello All,

The OmniPod 5 app for the iPhone was actually approved by the FDA around the 3rd/4th quarter last year. The iPhone app is now in Limited Market Release. Which if I understand it correctly it’s not far off from being a public release.

Ed

> On May 17, 2024, at 9:10 PM, Eileen Scrivani via Diabetes-Talk <diabetes-talk at nfbnet.org> wrote:
> 
> Again, the infusion set I was shown was very similar to the old Meo infusion set that Medtronic used to use. I had always been comfortable with the Meo.
> 
> The reservoir seems a little odd to me since I'm used to a tube/cylinder, and the Mobi uses a rather flat feeling piece that is housed in another flat piece. I have always been trained to snap the tube with my finger tip to knock out air bubbles and that will be more of a challenge, but I feel up to it. The rep was not concerned with bubbles, I don't buy into her thinking on that one though.
> 
> Eileen
> 
> 
> -----Original Message-----
> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of Veronica Elsea via Diabetes-Talk
> Sent: Friday, May 17, 2024 8:07 PM
> To: 'Diabetes Talk for the Blind' <diabetes-talk at nfbnet.org>
> Cc: Veronica Elsea <veronica at laurelcreekmusic.com>
> Subject: Re: [Diabetes-Talk] FW: [Tech-VI] t:connect iOS app for insulin pump could kill users, says FDA
> 
> The only thing I didn't really like when I looked at the Mobi was the collection of infusion sets. Tandem let go of the best one and I don't know why. But I too found the pump to be completely usable without assistance. I'm also still watching the Omnipod 5 for iOS.
> Veronica
> 
> 
> -----Original Message-----
> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of Eileen Scrivani via Diabetes-Talk
> Sent: Thursday, May 16, 2024 11:32 AM
> To: 'Diabetes Talk for the Blind' <diabetes-talk at nfbnet.org>
> Cc: etscrivani at verizon.net
> Subject: Re: [Diabetes-Talk] FW: [Tech-VI] t:connect iOS app for insulin pump could kill users, says FDA
> 
> Hi, 
> 
> I just met with a Tandem rep this week to go over the Tandem Mobi which just might be my next pump. I asked the rep about the software issue and she said it has in fact been corrected. The issue was quickly fixed and she said that regarding current software there are many alerts and checks that should prevent a situation like that from happening. The issue was the software was somehow draining the battery on the pump very fast.
> 
> I'm impressed by the Mobi and it appears  to me to be completely accessible (at least the items I went over with the rep). Voice Over works well with their app and allows control over carbs or units of insulin to be issued. Loading the cartridge with insulin, etc also appears to me to be completely doable by a totally blind person.
> 
> I am still going to meet next week with Medtronics to see the 780G pump again and will then make my decision.
> 
> Eileen   
> 
> -----Original Message-----
> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of Veronica Elsea via Diabetes-Talk
> Sent: Thursday, May 16, 2024 1:29 PM
> To: 'Diabetes Talk for the Blind' <diabetes-talk at nfbnet.org>
> Cc: Veronica Elsea <veronica at laurelcreekmusic.com>
> Subject: Re: [Diabetes-Talk] FW: [Tech-VI] t:connect iOS app for insulin pump could kill users, says FDA
> 
> Sounds like overkill to me, pardon the punn. Most Tandem users I know got the notice weeks before and the fix was already out there. If you're aware of what your pump is doing, you'd know what was happening. Recall? Sure. Of course, but I don't think the drama was necessary or very responsible on the part of the FDA.
> Just my dollar's worth.
> Veronica
> 
> 
> -----Original Message-----
> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of gary via Diabetes-Talk
> Sent: Friday, May 10, 2024 12:56 PM
> To: 'Diabetes Talk for the Blind' <diabetes-talk at nfbnet.org>
> Cc: gmelconian619 at gmail.com
> Subject: Re: [Diabetes-Talk] FW: [Tech-VI] t:connect iOS app for insulin pump could kill users, says FDA
> 
> Thanks for the heads up.  
> 
> -----Original Message-----
> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of Melanie Torrance via Diabetes-Talk
> Sent: Friday, May 10, 2024 11:39 AM
> To: Diabetes Talk for the Blind <diabetes-talk at nfbnet.org>
> Cc: Melanie Torrance <melanietorrance at icloud.com>
> Subject: Re: [Diabetes-Talk] FW: [Tech-VI] t:connect iOS app for insulin pump could kill users, says FDA
> 
> I am using the t connect version 2.7.1 without difficulty.
> Melanie
> Sent from Melanie's i phone
> 
>> On May 10, 2024, at 2:24 PM, Joy Stigile via Diabetes-Talk <diabetes-talk at nfbnet.org> wrote:
>> 
>> Hello DAN members,
>> I use the Tandem T connect App and pump but, I was never offered the recalled version!  
>> I never update any App until I know of other people already using the new version with ease.  I have had great success with the Tandem pump.
>> Warmly, Joy
>> 
>> -----Original Message-----
>> From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of Milton Ota via Diabetes-Talk
>> Sent: Friday, May 10, 2024 7:16 AM
>> To: 'Diabetes Talk for the Blind' <diabetes-talk at nfbnet.org>
>> Cc: Milton Ota <mota1252 at gmail.com>
>> Subject: [Diabetes-Talk] FW: [Tech-VI] t:connect iOS app for insulin pump could kill users, says FDA
>> 
>> 9to5Mac - Thursday, May 9, 2024 at 9:16 AM
>> 
>> 
>> t:connect iOS app for insulin pump could kill users, says FDA
>> 
>> 
>> 
>> 
>> Version 2.7 of the t:connect iOS app – which is used to control delivery of insulin by the t:slim X2 pump – has been urgently recalled by the FDA.
>> 
>> The FDA issued a Class I recall, which is reserved for products likely to cause “serious adverse health <https://9to5mac.com/2024/01/02/best-apple-health-features-apple-watch-iphone-accessories/>  consequences or death” …
>> 
>> 
>> What is an insulin pump?
>> 
>> 
>> Type 1 diabetes was previously known as insulin-dependent diabetes, as those diagnosed with the condition need regular injections of insulin. This is because their pancreas makes little to no insulin, meaning sugar is unable to be passed from the blood to cells. This causes sugar to build up in the blood-stream, which can be life-threatening.
>> 
>> Manual injections can be inconvenient, and are subject to human error (like forgetting one), so insulin pumps are a better solution for many. These automatically inject specific amounts of insulin when required, based on blood sugar measurements. Automatic pumps also operate while users are sleeping.
>> 
>> Pumps like the the t:slim X2 are controlled by an iOS app, which tells them when to inject insulin, and how much to inject.
>> 
>> 
>> t:connect iOS app recall
>> 
>> 
>> Version 2.7 of the t:connect iOS app has been found to crash, and is now the subject of an FDA recall <https://www.fda.gov/medical-devices/medical-device-recalls/tandem-diabetes-care-inc-recalls-version-27-apple-ios-tconnect-mobile-app-used-conjunction-tslim-x2> . A Class I recall <https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices#:~:text=Class%20I%20%2D%20a%20situation%20in,adverse%20health%20consequences%20or%20death.>  is the most urgent of the three categories, and is used only when “there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
>> 
>> A bug in the app is causing it to repeatedly crash and restart. Each time it does, it establishes a new Bluetooth connection, which drains the battery in the pump itself.
>> 
>> The reason for the recall is due to an issue with the software that may cause the mobile app to crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected.
>> 
>> Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin.
>> 
>> The FDA says there have so far been no reported fatalities, but there have been 224 reports of injuries caused by the bug.
>> 
>> 
>> What to do if you use the app
>> 
>> 
>> The bug has been fixed in version 2.7.1 of the app, so all users should ensure they have updated to this version.
>> 
>> Users should also ensure that the pump is fully charged before going to sleep, and always charge it at the first low-battery alert.
>> 
>> Image: 9to5Mac collage from Tandem Diabetes Care <https://www.tandemdiabetes.com/products/insulin-pumps/t-slim-x2-insulin-pump>  and James Lee <https://unsplash.com/@picsbyjameslee?utm_content=creditCopyText&utm_medium=referral&utm_source=unsplash>  on Unsplash <https://unsplash.com/photos/red-textile-in-close-up-photography-YpDkIh137ws?utm_content=creditCopyText&utm_medium=referral&utm_source=unsplash>
>> 
>> https://9to5mac.com/2024/05/09/tconnect-ios-app-recall/
>> 
>> 
>> 
>> 
>> 
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> 
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