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INR & INR Machines


INR Tracker
INR Tracker was founded in April 2012 as the definitive personal health management tool designed for Warfarin patients. With INR Tracker, patients can generate easy to read reports to help them and their doctor figure out what may be causing fluctuations in their Warfarin therapy. INR Tracker also provides easy to use tools to help you figure out what your INR level means, what foods have vitamin k and to help you understand the symptoms of blood clots. INR Tracker was founded by a couple affected by a blood clot.


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.

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.

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.

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.

My Experience with Finger Stick (Home) INR Machines

Patient's story on her use of a Home INR Machine and supporting company information.

INR


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.

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!

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.

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.

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."

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.

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.

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.

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!"

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.

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.

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 unvalidated 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.

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.

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."

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

*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."

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.

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.


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