Type 1 - Connect

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  • 1.  Faulty CGM's and the TGA

    Posted 21-02-2023 11:27

    Hi Crispin and all,

    On this forum there appears to be many discussions regarding faults in CGM's such as alarms, connectivity  etc. Any faulty  diabetic medical  device is an extremely important event and must be recorded for the benefit of users. I am highly  appreciatively of  having a subsidised  CGM from the NDSS. I am also very aware how lucky we are in Australia compared to other countries like the US  where many diabetics can't afford basic medications.

    Further, I have found that the manufacturers of the CGM devices give  excellent service when there have been any problems with my  sensor or the associated application on my iPhone, which is very commendable, yet I am still not sure how reported faults are recorded by the manufacturers. Further, yet minimally discussed, could thenew model CGM's overseas have already  ironed out some of these faults?

      Is it a catch 22 to resolve amicably the fault with the manufacturers yet the faulty devices are not recorded on a transparent government database?  

    I can only make the following suggestion that if there are faults in your medical devices to  not only  contact the manufacturers but our TGA on their website ( Therapeutic Drugs Administration) so that we know that all  faulty devices and concerns  are collated by the government body which then can refers  problems back to the manufacturers.  (See TGA Internet page below)  Hopefully, this will benefit all diabetics



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    Michael
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  • 2.  RE: Faulty CGM's and the TGA

    Posted 22-02-2023 09:52

    PLEASE DO NOT DO THIS.

    The last time somebody did this, they complained that their AccuChek Guide BG metre didn't work - and as a result every Guide metre was removed from sale, along with all of the associated test strips.

    The woman who complained genuinely thought she was a hero, for "standing up to big pharma" - of course, she was a new T2, and had no idea that she'd just DENIED EVERYONE ACCESS TO A MEDICAL DEVICE that we require to live.

    Please keep the knowledge of faulty equipment between us, the users, and the manufacturers.

    ACCESS TO A PRODUCT THAT IS MAYBE FAULTY IS BETTER THAN NO PRODUCT AT ALL.

    We need these to live - they are the best the world has currently. There are no alternatives to the 3 CGMs available on the Australian market, and they are not inter-operable - we need all of them available at all times.

    For the benefit of all diabetics; Shhh... 🤫



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    Amy
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  • 3.  RE: Faulty CGM's and the TGA

    Posted 23-02-2023 16:15

    Amy, I understand your point but don't know about the AccuCheck. 

    Fortunately, Abbot have now announced the issue with L2 and Android 13 and its reasonable to assume that they'll fix it.  So, I don't think we need to report them at this stage.  Its disappointing that they didn't announce the issue much earlier, because it had emerged elsewhere in the world before Australia.

    On a positive note, its forced me to use my L2 reader for alarms which is working.  It seems to have a more powerful near-field communication signal and hasn't suffered any sensor-not-ready issues.  It reads across a much greater gap to the sensor.  But the phone is more flexible with alarm options and has a much better (larger) screen.

    • looking forward to their L3 version - don't know why its not here....
    • Jock


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    Jock
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  • 4.  RE: Faulty CGM's and the TGA

    Posted 24-02-2023 08:47

    Android 13 is causing developers all sorts of issues, and the problems seem to vary between different brands of Android phones.

    As an interim measure until Abbott sort LibreLink out, you could try JuggLuco or DiaBox apps. They connect directly to the Libre 2 via Bluetooth and provide real-time BGL, not just alarms, every minute to your phone and watch. Your data will not be shared through Abbott's portal to your health provider, but statistics are available from the app in the event your health team wish to evaluate/criticise your diabetes management.

    As I said, an interim measure until Abbott sort it out. CGM has been a big part of my diabetes journey and I don't want to go back to the days of having to wave a reader over my arm.

     In the event you have a sensor failure it is best to not mention you are using a 3rd party app as, according to Abbott, they can cause sensors to fall off, or not insert correctly, and won't be replaced. Go figure... 

    At the end of the day it's about one's health care. If Abbott are in a position where they temporarily can't provide an holistic, government funded solution then I think it's appropriate to do what is required to maximise one's diabetic outcomes.



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    Roger
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  • 5.  RE: Faulty CGM's and the TGA

    Posted 24-02-2023 12:54

    Abbott has just provided an update to their L2 ap and I've installed it.   I'll have to wait for a new sensor to test whether the alarms work on my phone, because I initialised my current sensor with the reader, which means alarms are only sent to it.   (I don't know why Abbott can't send the alarms to both (or all) registered devices. )



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    Jock
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  • 6.  RE: Faulty CGM's and the TGA

    Posted 02-03-2023 10:01

    I've been using the updated L2 ap with a new sensor for a few days now and the alarms are working.

    So, the problems with Android 13 have been solved.



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    Jock
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  • 7.  RE: Faulty CGM's and the TGA

    Posted 25-02-2023 07:05

    Hi Amy,

    It's certainly disappointing to hear about the problems you have had with the  Accu-Chek Guide blood glucose meter recall in 2019. I was so  frustrated with my Aviva Expert, discontinued due to lacking Bluetooth. I can still get the strips and use the meter even though the model is superseded. Maybe it's time for me  to modernise with an update, supplied free from NDSS.

    Advocacy and the protection of human and consumer rights is fundamental to the workings of any functional democracy.  Just look at the amazing work of Diabetes Australia who have set up this forum, asking for advocates and demanding  from the government essential medical and health services for its members.

      Organizations  such as the TGA, ACCC, Medical Boards, even Royal Commissions, etc etc.  also  support consumer needs and   are usually staffed by highly educated professionals that make determinations on a wide range of issues.   

    Many of these bodies have been established to counter the huge power imbalances between individuals and mammoth multi national companies beholden to shareholder profits. Sometimes even simple questions are not answered such as why Australia has been excluded from new and improved CGM  models.

    The TGA recall of the Accucheck Guide  it appears was certainly not an easy decision, as is the recall of any medical device, medication or consumers goods. Manufacturers spend billions on research and development and need to see a profit to be accountable to shareholders. The questioning of and recall of medical devices and medications are a necessary event to save lives and protect the community, the most famous I  remember  being Thalidomide.

    The TGA  dealt with the issues surrounding the Accucheck Guide stating

    "It has been identified that Accu-Chek Guide blood glucose meters with serial numbers lower than 92911000001 and Accu-Chek Performa blood glucose meters with serial numbers between 68920000000 and 68925525056 (see image for serial number placement on the back of the meter) may:

    • Display E-9 Errors (indicating that the batteries need to be replaced)
    • Unexpectedly display the low battery icon
    • Have short battery life
    • Not power on.5"

    We are all very fortunate that there are avenues to get a response and resolution to problems regarding medical devices, medications and other consumer concerns. This  is a basic right for all of us and it is so important to know the avenues for redress.

    Take care,

    Michael



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    Michael
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