Warfarin INR Test Meters

PUBLISHED: Feb 13, 2018
Relevant to: Ambulatory Care, Home Health, Medical Office, Rural Health Clinics

The US Food and Drug Administration (FDA) has added new information about warfarin INR test meters for patients and caregivers using INR test meters in the home and for health care providers using INR test meters in a clinical setting.

The FDA has received Medical Device Reporting (MDRs) of adverse events about INR test meters that may have generated inaccurate results, and is providing this information to help patients, caregivers, and health care providers use these devices safely and effectively. An INR test meter is a portable, battery-operated meter, used to monitor patient response to Warfarin (also known by the brand names Coumadin and Jantoven) to ensure the medication is working effectively and being used safely. INR test meters may be used by health care professionals as well as by patients and/or caregivers in the home setting.

Updates to the website include:

  • Tips for patients and caregivers using INR test meters, such as how to take blood from a fingerstick and how to make sure the meter is working properly
  • Information for health care providers such as medical conditions that could affect test results and recommendations for confirming test results
  • How to report problems with INR test meters

All health care providers, patients and caregivers are strongly encouraged to voluntarily report INR test meter problems directly to the FDA through MedWatch, the FDA’s voluntary reporting program. The following are examples of some of the problems that may arise and should be reported:

  • Test strip or test meter defects
  • Quality control problems (liquid control solutions, test strip controls)
  • INR test meter fails to perform as described in the labeling
  • Discrepant test results (such as falsely low INR results as compared to a lab test) that caused or contributed to an incorrect warfarin or vitamin K dosage
  • Difficulty understanding the INR test meter or test strip instructions
  • Difficulty using the meter
  • INR test meter stops working unexpectedly
  • Unexplained bleeding, any other problems that compromise patient health or safety, or death

Included with today’s notice are example policies related to Warfarin therapy and using INR test meters. A link to the updated FDA INR test meter website is also provided below.

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