Brand of Machine that I was using: Roche CoaguChek S™

Diagnosis: Seronegative Antiphospholipid Antibody Syndrome  (SNAPS) & Lipoprotein (a)

Experience: After much convincing from other APS patients to get this particular machine, I got it.  My insurance company refused to pay for it – and since I was told it was basically the next best thing to sliced bread – I paid for it out of my own money….close to $2000USD.

I did many comparisons with the machine before I and my doctor would accept the machine’s numbers.  Things were working fine, well past the return date.  The periodic comparisons were fine.  Almost a year went by with no real problems or at least nothing that caught my attention.  However, it was during that time, others who had problems with this machine came to me and gave me in-house documents regarding this particular machine.  I was never told that this machine has a standard of deviation of 20% +/-.  I also found out this particular machine has problems with APS patients.

All the sudden I started having problems.  My INR was not matching my symptoms.  Well, both my doctor and I assumed my machine was reading right and we would correct the dose.  We played this game for a few months.   I suspected a problem but would check family members who aren’t on Coumadin® and their INR read right.  The controls were fine.  It wasn’t until I had another full blown TIA that I realized something was seriously wrong  - only this time my machine read 7.0.  I checked it again, 7.8.  I thought this couldn’t be right; my INR was 2.6 the day before.  I checked it again, 7.2.  Ran all the controls again – both liquid and electronic.  Those all read fine.  Of course, I got freaked and thought this was a bleed.  Went to the ER and my INR was really 2.3  Still having the TIA but that machine was off, really off.  I called the company.  They said their machine was fine if the controls were fine but they took the information down to file the incident.

We thought that was a fluke.  I checked my INR in a few days after an adjustment down.  I got a reading of 7.0.  I know that wasn’t right.  Hospital said it was 4.8.  I ordered a new box of strips, more liquid controls and started comparing batch to batch to INR.  The batches were matching up but none of it to the lab.  The lab readings were how I was feeling.  It got me thinking how long was this machine off a few months ago when we assumed it was right.  I was very lucky I didn’t have a full blown stroke because of the machine.  It was at that point I stopped using the machine.  I just couldn’t trust it any longer.

After about 6 months, I got my INR back on track by going to the lab once a week.  I thought I would spend the money and get a new box of strips since the others were expired and see if this expensive machine would work for me again.   I started again doing comparisons.  The machine was still off.   I am done using it.  I will deal with the hassle of going to the lab.  At least I know those INR’s are correct.    My Factor X matches my INR. 

I have smashed the machine into a million peices and really disgusted at what a waste of money it was.   

Next time I will do my own research before believing word of mouth, promotion from a group and taking everyone’s experiences into consideration....not just the good ones. 

I encourage you to do the same and make an informed decision.  Please read the limitation disclaimers for all of the machines on the market before you make your purchase. 

Don't believe what you read here?  Call the manufactures of these machines.  Yes, despite what you hear on other groups, there is more than one company that makes them.  Ask them point blank about the use of these machines with the diagnosis of APS.  Lets use some business logic, if the percentage of people having problems were truly so low, they would still try to sell you the machine (they are out to make money - remember), with the "only a few percentage of the APS population has a problem" type of line.  They don't say that.  They do their best to discourage you from making the purchase once they know you have APS - assuming the vendor / sales rep has ethics.

Ask those parties & agencies who are pushing these machines on you, what is in it for them.  Do they get kick backs for referrals or own stock in the company?   Ask them why they attempt to discredit every negative experience as bunk or urban legend?  Ask them how they "know it isn't credible".  It isn't stiring up drama and making "urban myth"; it is about education.  How do they know it hasn't be reported to the manufacture and the FDA?

This is your life and it may be your death that these finger stick machines may cause if you fall into the limitations category.  Please report any negative experiences to the company.  That is the only way they can try to fix this. 

Do your comparison draws regularly.  Don't go with the "well I feel good today and it is in the range where I feel good, it must be ok" attitude or "I haven't had a clot or a bleed, it must be ok." attitude.  That is faulty logic.  Don't go with, I am not in a flare, the machine is right" thought, either.  You may not know when your antibodies are going up or down.   And please don't just subtract or add a standard number or the average it has been off.  It may not always be that much off - it could be worse than that (or with some luck - better).

I have also been reading arguements that the errors "...never recomend one of these machines to a person who was permanantly positive for LA as the machine would just not work for 33% of them (the other 66.6% would still be OK, but the constant worry of a possibility of a false high would be too much to bear."  Who would buy a machine (or any other product for that matter) that may only work 66.6% of the time?  Especially when you are not sure what 66.6% of the time that is that is and once again you may not know when your antibodies are going up or down.  You may not always be having a "flare".

Seriously, I have to ask, what kind of money are these people, groups and organizations making on the promotion of these machines?  I mean really, why are they going to APS conferences and standing there promoting these machines?  Not a single disclosure made.  Why?

Happy Reading. 

Use these finger stick machines in general at your own risk. 

If you don't have autoimmune problems like APS, these machines may be ok for you but be fully aware there are problems with these machines and don't let anyone tell you there isn't a problem when it comes to APS.  I have collected enough factually supporting information to support my stance...add in my personal experience and others.....well.     I still do not understand how groups can refute what the manufactures of these machines say.

Buyer Beware! 

Please note I also have faxes from Roche.  If you are interested in them, please contact me.

http://img.photobucket.com/albums/v470/Eyzrbrn/APS/Roche.jpg

(And a quick shout out to Roche since they seem to be so very intersted in my page.  Thanks for stopping by, the more you click the higher in the search engines it goes. *wink*  Pity, the information came from your company.  I am just sharing the truth with people, that is all.)

Stuck with one of these machines, don't try selling it on eBay, they will pull it off.  They started cracking down on that a long time ago.  You need a prescription for it.  That is an FDA violation.  You can't sell it because you would be selling something that requires a prescription to purchase in the first place, that is also a FDA violation.  And you could be held liable for any problems the person you sold it to has.  In the end, you will end up giving this boat anchor away or destroying it.  My suggesting is trying donating it to a free clinic that could use one and get the tax write-off.

    
Here where my comparisons. Now there are times that I thought the machine was right and wrote down INR didn't match symptoms but didn't go in because a recent comparison was right....but now knowing better...chances are it wasn't right. Some of those were the difference of doing something and not. As fast as it is not working right it is...and when do I know when it isn't. And I supposedly have no antibodies. Hummm....And look the first 10 INRs matched. So I couldn't return the machine. 

Please note: My antibodies had been documented as NEGATIVE the whole time.

Supporting Links:

*INR Monitoring in Patients with Antiphospholipid Antibodies with Finger Stick INR Machines. by: Stephan Moll, MD. A superb way to monitor INRs (International Normalized Ratio) in patients on oral anticoagulants who do NOT have antiphospholipid antibodies (APLA) is though use of “point of care instruments”, where the INR is tested on blood from a finger stick. This method gives fast results and is used by many physicians’ offices and by some patients at home. However, in patients with APLA on oral anticoagulants these instruments may give inaccurate readings.  

Anticoagulation Forum "Recognizing the growing importance and widespread use of antithrombotic therapy for individuals with thromboembolic disorders, the Forum seeks to develop a network of professionals committed to this therapeutic modality in order to exchange information, provide medical education, and pursue scientific investigation, with the ultimate goals of providing professional development and enhancing the quality of medical care."  

Antiphospholipid Antibody Syndrome (APS) - NO to Home INR Machines!! I started this blog to help get the word out that Home INR machines are NOT safe to use for patients with Antiphospholipid Antibody Syndrome. If you have APS, please read! Thanks!  

CoagCheck Systems Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the CoaguChek, CoaguChekS and CoaguCheckXS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.  

CoaguChek & CoaguChek S Strip Insert Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the CoaguChek & CoaguChekS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.  

CoaguChek XS System - Patient Experience Registration Required to read story. "I called Roche and expressed my concerns about the reliability of the machine. They told me that at higher INRs (above 4.0) the machine becomes less reliable. They also told me that the machine doesn't work very well for people with Antiphospholipid Antibodies because these same antibodies are on the test strips! She said that especially when someone with APS is having a flare up the machine may not work well due to the high level of antibodies in the blood."  

CoaguChekXS Strip Insert Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the new CoaguChekXS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.  

Devices for ambulatory and home monitoring of blood pressure, lipids, coagulation, and weight management, part 2 Am J Health Syst Pharm.2005; 62: 1894-1903. Kelly L. Scolaro, Pamela L. Stamm and Kimberly Braxton Lloyd Copyright © 2005 by the American Society of Health-System Pharmacists.  

Factors That Influence INR system Comparisons List includes Antiphospholipid Antibodies. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.  

For those inquiring about HOME INR machines... Registration Required to read this patient experience. "You're putting your life into a machine that is KNOWN to be wrong with APS patients...think TWICE...THREE times...FOUR times and Just say NO!"  

Hemochron Jr. Package Insert Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.  

Home INR Machines and Antiphospholipid Antibodies Home INR machines do not give accurate readings in about 1/3 rd of patients with antiphospholipid antibodies who are on warfarin. This is not due to the machine malfunctioning, but likely due to antibodies interfering with the test method of the home INR machines. In one third of patients with antiphospholipid antibodies the INRs read by the home INR machines are unreliable: (a) they either read too high, compared to INRs tested in a laboratory from an i.v. stick (reference 2), or (b) the instruments flash up an error message (reference 1). This inaccuracy is likely caused by the presence of the antiphospholipid antibodies. Since antibody levels can fluctuate over time, the instrument may give accurate readings at times when the antibody levels are low, but inaccurate ones at times when the levels are higher. This is a phenomenon not unique to the Coaguchek® instrument, but is also seen with the ProTime® and the INRatio® instruments (reference 1,2). In patients who do not have antiphospholipid antibodies the home INR machines give reliable readings and are a good way to monitor warfarin therapy (ref. 3). Last Updated: 8/22/06  

i-STAT® PT/INR test The i-STAT® PT/INR test is a whole blood determination of the prothrombin time used for monitoring oral anticoagulant (warfarin) therapy. The test determines the time required for complete activation of the extrinsic pathway of the coagulation cascade when initiated (activated) with a thromboplastin. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks.  

INR Self Testing INRs from POC instruments are unreliable in about 1/3rd of patients with the clotting disorder called antiphospholipid antibody syndrome (APLA syndrome) who are on warfarin. In these patients, the POC devices give INR readings that are too high, or the instruments report error messages. This is the case with any of the 3 instruments on the market. If you have APLA syndrome, your INRs should be checked from blood drawn from a vein and tested in a laboratory.  

INRatio by Hemosense Representatives & Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Please see: http://www.hemosense.com/docs/5500317_TechBull108_AntiPhospholipid_RevA.pdf  Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.  

INRatio Monitor and Interfering Substances Anti-phospholipid antibodies can disrupt the phospholipid in the PT reagent that is necessary for the clotting reaction to occur thus artificially elevating the INR. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.  

MAUDE Adverse Event Report Caller alleged discrepant results compared with the lab. Results as follows: date: 01/12/07, inratio: 6. 1, lab: 3. 6. Ts updated this case on 01/18/2007 and 01/19/2007. 01/17/07, first test inr = 7. 5(old strip). Second test inr = 5. 5(new strip). Date: 01/19/07, inratio: 6. 5, lab: 4. 0. Caller has antiphospholipid antibody syndrome and recently had an episode of multi organ infection resulting in failure of adrenal glands.  

MAUDE Adverse Event Report Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: early 2007, inratio: 2. 1, lab: 8. 5, mean: 5. 3, confidence limits: unable to be determined. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. The confidence limits cannot be determined. The readings are considered inaccurate based on "area outside the acceptance region" table. The results are considered discrepant within the context of the documented variability for inr testing. Therefore, further testing is required at this time. In troubleshooting found that the pt has antiphospholipid antibody syndrome. It was explained that possible interferences may be due to the varying levels of the antibodies. Pts condition may cause the discrepant errors.  

MAUDE Adverse Event Report Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: 01/05/07, inratio: 6. 1, lab: 3. 8, mean: 4. 95, confidence limits: 2. 8-7. 2. Date: 01/15/07, inratio: 4. 3, lab: 2. 8, mean: 3. 55, confidence limits: 2. 2-5. 3. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. Both inratio and lab values are within the confidence limits for inr testing. The results are not considered discrepant within the context of the documented variability for inr testing. Therefore, further testing is not required at this time. Per text "pt has antiphospholipid antibody syndrome, (cardiolipin-positive, lupus-negative). " pt's condition may be causing interference.  

My Experience with Finger Stick (Home) INR Machines Patient's story on her use of a Home INR Machine and supporting company information.  

Patient Variables in PT/INR Testing with INRatio Technical Bulletin from HemoSense makers of INRatio. Clearly states that APS effects its results. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.  

Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies. SL Perry, GP Samsa, and TL Ortel Thromb Haemost, December 1, 2005; 94(6): 1196-202. Antiphospholipid antibodies can influence the results of clotting tests in a subset of patients, which can be a major obstacle in monitoring warfarin.The aim was to determine if point-of-care testing of the International Normalized Ratio (INR) is influenced by antiphospholipid antibodies. Please note the manufacture of this machine helped fund this study.  

Protime Machine Representatives clearly state that this machine has problems with APS patients and patients with the Lupus Anticoagulant. Waiver for patients with APS must be signed. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.  

ProTime Microcoagulation System Package Insert Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.  

Questions and Answers: For Use with CoaguChek® Test Strip Urgent Medical Device Correction (UMDC) 06-266 and Urgent Medical Device Recall (UMDR) 06-267 11/16/06: CoaguChekS now has a 30% +/- acceptable standard of deviation.  

Thoratec Receives FDA Warning Letter, Plans Recall (ProTime) Thoratec’s International Technidyne Corp. (ITC) division has received an FDA warning letter citing concerns about its quality systems, specifically those related to certain lots of its ProTime System anticoagulation monitoring device.....of incorrect readings of patient blood coagulation levels.  

Validity of Criteria Used to Evaluate Fingerstick Devices That Assess International Normalized Ratio Medical Decision Making, Vol. 26, No. 3, 239-246 (2006). Conclusion. The invalidated criteria used to predict warfarin dosing agreement between 2 INR measurements are associated with large error. Warfarin dosing decisions should be measured directly in such assessments.