Preparing to go to the FDA

[Protimenow]

I reported on some issues with a particular lab. In June, it reported an INR of 5.1. It repeated the test again, and got the same number. Apparently, they didn't factor in that a) the blood may have been mishandled, b) the tech wasn't experienced at running the test, c) they may have used a faulty reagent, or d) their equipment failed to accurately run the tests. My meters gave me an INR of 2.7, and two other labs reported INRs of 3.5 and 3.6 (still, somewhat disturbingly higher than 2.7, but a lot better than 5.1). I reported the error to my physician, who thanked me, and told me about another patient whose INR was consistently in range, and who the lab reported had an INR of 7.1.

Two weeks ago, I had another blood draw, with a similarly high (and erroneous) INR of 5.1. I tested on two meters, both reporting a still somewhat high INR of 3.7. I've changed my dose since then.

I left four messages on their portal. My last message asked why they hadn't responded.

Yesterday, I got an answer -- because they're IDIOTS. The person responded, thanking me for my 'inquire' (not for my inquiry). He told me to take it up with my healthcare provider (all he did was presribe the damned test - he has NOTHING to do with the operation of the lab or its procedures), and apologized for the 'inconvenience.'

This wasn't an 'inconvenience' -- most patients don't know enough to self-test or challenge their blood test results. Physicians trust the labs - especially if they 'repeat' the tests on mishandled blood and get the same result. They'll prescribe a lower dose, or a skipped dose of warfarin, and then retest at some time in the future. My point is - if the warfarin dosage is lowered for a person whose INR is actually in range, it could, conceivably, cause the INR to drop below 2. If left long enough, this patient can form a clot, and, in extreme cases, have a stroke, pulmonary embolism, or other things that MAY be fatal. Perhaps it's 'inconvenient' for me, but it could be debilitating or fatal for others.

I sent a reply to the ***** who sent me that boilerplate message -- but it bounced back because the message I got was from a 'no-reply' email address.

I've contacted the executive offices of the company that ran the test - with no response so far.

I don't even know why I contacted them.

I'm planning to inform the FDA of this dangerous situation, and leave it to them to try and sort it out.

The report won't be for me - it'll be for the unsuspecting others who can be seriously injured by this lab's cavalier and unconcerned approach to the accuracy of this test.

 

[Agian]

Go for it my man.

 

[Protimenow]

LondonAndy -- I'm hoping that your angry emoji was for the lab, and not for me.

I'm still waiting to hear from the lab, and for a callback from the FDA.

I'll share more once I get some responses.

 

[pellicle]

I'm hoping that your angry emoji was for the lab, and not for me.

if I was you I'd be angy at the lab, I've never seen evidence to suggest that Andy values "the system" over "personal health" so it would seem more natural to assume that he's angry at the system rather than angry at you for "daring to challenge the system"

Thats just how I'd see it.

 

[Protimenow]

That was my thought, too - but I wanted to be certain.

 

[LondonAndy]

Oh! Yes, happy to confirm I was saying I would be angry with the lab too. As you say, many people would take potentially injurious decisions based on their wrong reading, and it is important they accept this and improve. Sorry for any misunderstanding.

 

[rich01]

For what it's worth, you might contact your Congressman and/or Senator as well. Let someone on their staff shepherd it through the system.

 

[catwoman]

Protimenow, was this a lab with locations across the U.S.? If so, which one is it?

 

[nobog]

Calibration records - this will go nowhere without that - you need it for the labs and yours - which is a very good question (of which I have no answer) of how that is done and what is the standard.

 

[Protimenow]

nobog -- the tests that I referred to last June were compared to two blood draws at other labs, and to two tests on my Coag-Sense meters. I'm not sure about calibration issues -- but I think that it would be odd to have a lab with results that were contradicted by two other labs, and the doctor who prescribed the first blood draw telling me about another patient whose INR was always in range suddenly having an INR of 7.0. This may be strong enough evidence to indicate that the lab probably screwed up.

In regards to my test this month, I've had consistent INR levels, based on my Coag-Sense meter(s), before and after this blood draw. After the blood draw - with a result of 5.1, I tested on two different Coag-Sense meters and got identical INRs (3.6 - higher than I'd like, and I've adjusted my dose), but still 1.5 lower than the lab. Also - having checked with Coagusense, they stand behind the accuracy of their meters.

Catwoman -- it's great to see you back. I'm hesitant to name this lab, for legal reasons. They can try to bury me, and have the wherewithall to shut me up. I'll leave this to my dealings with the FDA.

I've called them, and so far, haven't even gotten a reply (other than the totally inadequate, poorly worded, no-reply boilerplate BS that one of their people sent me).

rich01 - contacting my Congressman is a thought - I hadn't considered that. He's not one of the congressmen presenting at the impeachment trial but may still have his attention focused on other areas. However, I can call his office and see if they have any interest in contacting the FDA.

One more thing - today's meters don't require calibration - the code chip for the CoaguChek XS, and the controls on the Coag-Sense take care of most of that. With the Coag-Sense, there are also high and low INR control strips.

As far as labs go, I'm aware that suppliers of the reagents that labs use provide values for their reagents and, if a test is performed properly, the results should be accurate (or within a range defined by the ISO). If the lab receives blood that is mishandled, or something happens to corrupt the reagent (is this possible), or if the person running the test does it wrong, what good would calibration do? And, FWIW, for a lab to say that they repeated the test and got the same result - isn't this just saying that a) mishandled blood, or b) faulty equipment, or c) mislabeled of compromised reagent (or inaccurate settings on the test equipment), or d) operator error were repeaated? It says little about the value of a repeated test, if the same errors are repeated during the 'validation' re-test.

There should be some control tests, against which lab equipment is tested. Perhaps there is. Perhaps this lab hasn't used it in many years. At a less granular level, there should be some kind of statistical test comparing average values over time for ALL samples submitted. Even though different tests may be prescribed, I'm thinking that an overall spike may suggest the possibility of testing errors. Perhaps even more significant would be to run a statistical analysis on all tests with INRs higher than 2.0, over a few different time periods. A spike in THOSE values may even more strongly suggest that something is amiss - either in the earlier time period or in the later one.

There should be a reason why this lab's results are so far off of those from two other labs.

I remember years ago, when I went to an AC Clinic that used the Hemochron, they occasional calibrated this meter against lab results. This just isn't the case with the current meters.

 

[tommyv44]

Congratulations! You need to be you own best advocate today!

 

[nobog]

Maybe of some help here:
https://www.advancedcardioservices.com/coaguchek-xs-accuracy

 

[Protimenow]

Self-advocacy is certainly important. But to do it right, I've got to have solid facts behind me -- and I DO have some -- test results from two other clinical labs to show that the one I plan to complain about provided incorrect results -- records of message acknowledgments from the lab, and their inadequate response. Records of unanswered phone calls to the lab, and to the lab's corporate offices. Years of test results, and a statement from the manufacturer of my meters - Coag-Sense firmly standing behind the accuracy of their meters.

A few years ago, after I had a TIA as a result of my meter's errors (it said 2.6, when my INR was actually around 1.7), I launched a quest to find the most accurate meter. I compared results from one meter to another, and from meters to lab. In my experience, the Coag-Sense was slightly lower than the lab, and the Coagu-Chek XS was slightly higher. Both meters were within 20% or so of the lab results - except when the INR was higher than 3. The CoaguChek XS was increasingly higher than labs the higher the lab showed my INR to be. This is also documented in a variety of other studies - I haven't read the one that NoBog sent the link to (and I will), but I suspect that it will probably confirm the findings of other studies.

In the case of this complaint to the FDA, the XS doesn't factor in. I still have no XS strips, and I did not use the XS to compare to this lab. The issue of accuracy or errors by the XS weren't involved in these issues.

Thanks to everyone for your support and suggestions.

 

[tom in MO]

Physicians are the bread and butter of laboratories. I'd ask the doctor to go after them as well.

 

[Protimenow]

I mentioned this to my doctor. He didn't seem to be interested. I'm now in a PPO, and he probably has a choice of this ONE lab - so he may be hesitant to shake things up with them. An angry lab could, perhaps, delay results, not return phone calls as quickly as he would like, or do other things to annoy him. Plus - the lab could claim that the error is a 'fluke' that won't happen again, or that I'm a crackpot for suggesting that the lab made an error.

 

[rich01]

You're just the patient, so really don't have a right to complain. The doctor orders the lab and the insurance company pays for it. To the lab, you are just a nuisance.

Sorry, but that's how I feel after most doctor appointments. Here's a prescription, now go away.

 

[Protimenow]

I told this doctor that I had two bad knees - that an MRI of my left knee was interpreted to say I need a knee replacement right away. I didn't get it.

I told him that I had the same issue with my right knee.

He pushed on my patella on both legs,and moved my leg up and down. 'They're crunchy,' he said. I could have told him that. He prescribed x-rays - as if that would be at all diagnostic. My right knee has been in pain ever since his exam.

Yes, to the labs, patients are a nuisance - especially when they question the accuracy of a test.

In my case, I must have rattled some cages there - the corporate office had a Patient Advocate call me - I explained to her the reasons why an inaccurate INR could result in life threatening (or fatal) events, and told her that my interest was not for myself, but for others who blindly accept the test results or doctors who don't know better.

She said that she'll get back to me.

She just might...

 

[rich01]

I hope you get a positive response.

You might check out red light therapy for your knees. It used to be just laser, but they found leds work just as well, so buying a red light is getting affordable. I use one on my chest every morning. I also try to do 1 hip and 1 knee every morning and then the other side the next day. The red light penetrates about 2" below the skin and promotes healing. I don't know if it would help with your knees or not, but might be worth checking out. Joov sells them and has some good videos and articles, but I can point you to a cheaper source if you decide to get one.

 

[Protimenow]

The response that I've gotten so far seemed as if the person was interested in what I had to say. I hope that I convinced her that I'm not a crank or a crackpot, or out to get some kind of financial reward - or something else. I hope I convinced this person that my only concern in contacting the lab - and probably the FDA - was for the people who may be undercoagulated as a result of the incorrect INRs and could suffer dire health consequences.

Thanks for the information about the red light. I happen to have a LightStim and another LED unit that was designed to stimulate collagen under the skin. I bought it for my wife, but she has me use it, too.

I'll try it on my knees and see if I get any relief. I'm also taking Mens Collagen (which helped in the past), and on alternate days put multicollagen in my morning hot cocoa.

I didn't even want to bring these things up - but appreciate your suggestion. Two things - it's not fun (the word I discarded is hell) getting old (and wearing out some important parts), and it's less easy when you can't take much for the discomfort (I learned this term when my wife was pregnant - they didn't describe 'labor pain' - they called it discomfort. If I was a woman, I'm sure that I wouldn't agree with that term).

 

[tom in MO]

If you have arthritis in the knees, you might find this interesting: 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee: Error - Cookies Turned Off Link appears to work, but I cannot edit the text.