Officially done with CoagSense

[Protimenow]

I used to be a very strong advocate for the Coag-Sense meter ---- but not anymore.

Over the past two or three years my results have consistently been lower than the Coaguchek -- by as much as 1.2 points.

Today, I took a test as a somewhat final check to compare results to the Coaguchek and had a rather disturbing experience: the meter took convincing even to start working -- there was a software update - but I couldn't start it because the touchscreen didn't work. Restarting it a few times got it to work -- almost -- now it wouldn't recognize the strips.

Finally, after a few tries. I was able to run a test -- my blood stayed in the transfer tube for a minute or more before I could transfer it to the strip, but my result was a surpnising 2.0 -- the blood sitting in the tube should have coagulated during the delay in putting it on the strip, but didn't.

My Coaguchek result was a more credible 3.2.

My trust in this meter is gone. The company was unresponsive to some of my previous messages.

If you still use this meter, I suggest that you validate its accuracy with a blood draw.

The meter may work just fine for YOU. but I think that I've done my last test with my CoagSense meter.

(If you trust your meter, I have a few strips that I don't need -- free to the first person who asks for them.

 

[tommyboy14]

These meters should clearly be a little bit more regulated. In many European countries, including the UK, you can only use a government approved one (I think in the UK you can only get Coagucheck). There is also a requirement to have your home meter tested against the hospitals twice a year. At last weeks test my home meter Coagucheck was 2.6 vs hospital one 2.5 from the same blood draw.

 

[Protimenow]

I may have been slightly premature in my condemnation of Coagsense. but I'm still through with it as the meter that I trust with my life.

I've gone through a few years of results. and found that the Coagsense result was consistently lower than the Coaguchek. They still are.

However, the differences seem to have gotten larger.

Roche's meters were -- and still are -- the most used meter for self testing and at doctor offices as far as I know.

The consistent differences between the two meters is troubling.

OTOH, this meter's potential underreporting of results can help me to keep my INR above 2.0 -- even if it underestimates the "actual" INR.

I think I should have a lab test or two before condemning the meter.

I'll update this when I do a bit more testing.

 

[Protimenow]

My doctor issued a standing order for INR testing. I'll again do some validation testing to see which meter gives a result that's closest to the lab (assuming, of course that the lab's result can be trusted).

I will probably be talking to CoagSense and see what they have to say, but this won't negate the issues that I've had with their meters, nor explain why the results are almost always considerably different from Coaguchek.

Another point that I'll be considering is the well documented tendency for Coaguchek meters to report values that are higher than lab results when the INR increases.

The differences DO seem to have remained fairly consistent.



My blood draws may shed additional light on the issue of accuracy.

 

[Protimenow]

I plan to finally get a blood draw tomorrow. I'll also test with my CoagSense and XS.

In a week or so, I hope to have a better idea about the 'accuracy' of the meters -- assuming, of course, that the lab results are close to correct.

 

[Protimenow]

I just had my blood drawn. I already tested with both meters.

CoagSense: 1.7
Coaguchek: 2.6

The results are outside the 20% window.

If I believe the Coagsense, I would immediately increase my dose. I don't want to risk a TIA.

If I believe the XS. I would make no changes. My INR is right where I want it to be.

Years ago, the lab results were almost an average of the two machines.

I'll know the lab results in a few days.

 

[carolinemc]

I just had my blood drawn. I already tested with both meters.

CoagSense: 1.7
Coaguchek: 2.6

The results are outside the 20% window.

If I believe the Coagsense, I would immediately increase my dose. I don't want to risk a TIA.

If I believe the XS. I would make no changes. My INR is right where I want it to be.

Years ago, the lab results were almost an average of the two machines.

I'll know the lab results in a few days.

The lab I use , at the hospital, uses Coagcheck, up to date. And I like to do it there, we get the results fast. If it is too high, the regular blood test is done. like 4.0 or higher.

 

[sharky7]

I just had my blood drawn. I already tested with both meters.

CoagSense: 1.7
Coaguchek: 2.6

The results are outside the 20% window.

If I believe the Coagsense, I would immediately increase my dose. I don't want to risk a TIA.

If I believe the XS. I would make no changes. My INR is right where I want it to be.

Years ago, the lab results were almost an average of the two machines.

I'll know the lab results in a few days.

WOW, and here I am thinking, that is until your last few comments, that both machines were made by the same company, when they are not! The machine i bought on Ebay new, a few years back is a Coaguchek and so far I am very happy with it. It never seems to be exact what the VA Hosp test comes up with, although I do know where I should be for that test to be where we need it to be!
I eat like most I think, and eat what I want when I want it, VA tests at about 4-5 apart now, unless I test out of range. And now after testing for a few years now, they even tend to give a bit of a leeway one way or another! That is before they tell me that they need to test in a weeks time to make sure I am alright, and they do know that I home test. i broke down and told them.
The lab you are now waiting for, is it a LAB, DOCs office, Hospital or what, hope that ya dont mind me asking.
At the one testing place one heart doctor sent me to have the same machine that I use, that was over a year ago, AND I still do not know what and how the VA HOSPITAL uses, my GP nurse at the VA said one time she thought they used the same machine I use, but we were not sure!
And WOW to that test result you got and posted here, and with the same blood sample, I do not believe they were suppose to be that different, and it being a good thing. something going on there for sure I would think, and ya need to be sure, good luck in trying to figure it all out! [my range is only 2.5-3.5] VA recently tested [MAY 17th] and MACHINE was 3.1, and VA was 2.9 which I think was awesome! My test was done on MAY-16th, the day before the VA test!

 

[pellicle]

WOW, and here I am thinking, that is until your last few comments, that both machines were made by the same company, when they are not! The machine i bought on Ebay new, a few years back is a Coaguchek and so far I am very happy with it.

I've gone out a few times and said go with the big name, the USA based one only really sells because somehow it flew under the radar of regulations in the USA. It basically has no market presence outside of the USA AFAIK.

Its junk IMO

 

[sharky7]

I've gone out a few times and said go with the big name, the USA based one only really sells because somehow it flew under the radar of regulations in the USA. It basically has no market presence outside of the USA AFAIK.

Its junk IMO

And I would add to that, the way things are currently, in the USA we have more choice then alot of places in the world to get all sorts of things! And I do not need to add, I think, when it comes to items like this, and that it has a large impact on your health in more ways then one, it makes me really love this place when you may hear truth from those that know first hand! and then the odds go way up when the time comes to choose/decide, with what happens to be perhaps, a once in life time choice.

 

[Protimenow]

Actually, there is choice in other parts of the world. There are meters made by Siemens, and there may be others in Europe. I haven't done an extensive search, bur I think that there are a number of choices that aren't available in the United States.

Coagsense had to pass the FDA testing to be permitted to sell their meters in the U.S.

My experience is that the CoagSense results were always a bit low -- especially when compared to the XS. I considered this to be an advantage because an INR below 2.0 scares me -- and even if the XS gives me a result that's 1.0 higher, I'll know that my INR isn't dangerously low.

At this point. I would be more comfortable with a result that's closer to the lab.

By this time tomorrow. I'll know the lab results.

And, yes, the CoagSense meter and Coaguchek meters are made by two different companies.

 

[jeffp]

Just to add to the fight… when I started self testing 18 years ago (how time flies) I used an INRatio meter. The thing was always within +/- 0.1 INR units of the lab test. And the strips were a tad more than $1 a pop.
About 5 years into it, the FDA revoked approval of the meter as it was found to be inaccurate in the presence of heparins. I never used it for bridging, so didn’t care. It was the company’s only product and soon after supplies were not to be found. Got a Coaguchek from a local medical supply house and went rogue. No one was any the wiser.

 

[pellicle]

@jeffp , interesting history, thanks for sharing that detail

 

[Protimenow]

I probobly shouldn't be surprised. The lab reported an INR of 2.3 -- roughly average between the results of the two meters.

It's been roughly this way each time I tested with both meters and made a lab comparison.

There is no conclusive evidence to conclude that the lab results are more accurate than the meters.

I DO think that the CoagSense result is a bit low. XS results have always been a bit high (for me, at least). but are trusted by millions of users and clinics.

This probably doesn't change my approach to each meter -- if I want to be pretty sure that my INR doesn't tip below 2.0, the CoagSense is the best option. Although I have test results going back for more than a decade, I didn't find XS results reporting results that my INR was above 2.0 when it wasn't. In fairness, I've tried to maintain my INR at or above 2.0 even since I started self testing in 2009.

This thread was started when the touchscreen didn't work and I wasn't able to use the CoagSense meter. I'll probably stay with the world standard -- the XS and may rarely use the CoagSense until my supply of strips runs out.

 

[Protimenow]

Just to add to the fight… when I started self testing 18 years ago (how time flies) I used an INRatio meter. The thing was always within +/- 0.1 INR units of the lab test. And the strips were a tad more than $1 a pop.
About 5 years into it, the FDA revoked approval of the meter as it was found to be inaccurate in the presence of heparins. I never used it for bridging, so didn’t care. It was the company’s only product and soon after supplies were not to be found. Got a Coaguchek from a local medical supply house and went rogue. No one was any the wiser.

My experience with the InRatio was pretty catastrophic, I trusted my life to that meter.

It was giving me a 2.6 for weeks until I had a TIA -- the hospital tests were as low as 1.7.

After that, I started testing with a variety of available meters, looking at agreement between meters and the lab.

I wasn't sorry to see the Hemosense go -- it hurt me. and who knows how many others. (No. I wasn't taking heparin)

 

[jeffp]

Sorry you had complications. They’re all gone now, so not to worry about that. I’m waiting for the day when whatever the unit of day is gets recalled for some issue, real or perceived. Then they’ll sell us the newest latest and greatest.
My INR is pretty stable from test to test for years. I aim for the higher end of my target range as a hemorrhagic stroke is statically less likely at the high end than an ischemic stroke is at the low end. Would rather avoid either, but we have to take what life throws at us.

 

[Protimenow]

I don't expect the Coaguchek meters to ever be recalled -- there's way too much positive track record for this product line. This isn't to say that they haven't had issues -- they've recalled some strips.

For Roche, the latest and greatest are new models with bells and whistles (color screen, for example) but still using the same strips (although there may actually be a new version of the strips). There are probably WAY TOO MANY XS meters in use for Roche to try to discontinue.

Meters go through extensive testing before they get approved by the FDA. I expect recalls of meters to be extremely rare.

 

[jeffp]

I don't expect the Coaguchek meters to ever be recalled -- there's way too much positive track record for this product line.

I say this with tongue in cheek…you’re way too optimistic.

He’s a parallel story: some years back I bought a stand alone internet radio. Worked great. A few years later (2020) the company decided to no longer support the directory service. All the stations were still there, you just couldn’t pick and choose what to listen to from the list of thousands. The hardware was fine, they yanked the software. Some months later they had new software and directory service that wasn’t supported on the old hardware. They’d be happy to sell me the new model at 10% off. It’s in a box somewhere in the garage now.

I can see the profit motive for “let’s drop all these self testers. We’ll support our clinics and docs. $5-600 for a new meter- pfft - peanuts for a business. They’ll recoup it in testing fees in no time.” And poof - all gone.
(Actually this is a pretty good idea from a business point of view.)

It would be like Tesla deciding to charge a software subscription for heated seats. (oops - they already did that).

Like the saying goes: follow the money.

 

[Protimenow]

There are a few realities that you're missing:

The XS is a medical device -- unless the device is dangerous (like the InRatio was, and the FDA forced the removal from the market) , it takes a while to discontinue a product. A few years ago, Roche discontinued the Coaguchek S from the market -- this was a phased process and came with considerable advance warning.

By contrast, the XS has had upgrades to its meters, but the meters take the same strips. There's the possibility that at some future date, Roche may try to phase out strips for the XS (reportedly, there's a new strip that only works in the new meters, If this happens, there will be a LOT of self testers (and maybe clinics that would be impacted by this. I'm not sure how this would go over if it happens)v

Roche is the only source for the strips, so these will continue to be a solid revenue source for them.

My wife used to work for a doctor with a small practice. There is no way in hell that he would have bought a meter -- especially for thousands of dollars -- he would have had a lab do the testing, and send the patient to a lab that probably doesn't use a meter for testing, This wouldn't help Roche at all.

If I was in any position to advise Roche, I'd tell them to continue with their razors and blades strategy -- make money on the meters and a lot of continuous income from the strips.