Lawsuit Investigation Looks into Accuracy of Omron Blood Pressure Monitors
Last Updated on September 28, 2023
Investigation Complete
Attorneys working with ClassAction.org have finished their investigation into this matter.
Check back for any potential updates. The information on this page is for reference only.
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At A Glance
- This Alert Affects:
- Anyone who purchased an Omron Platinum model BP5450 blood pressure monitor within the past three years.
- What’s Going On?
- Attorneys working with ClassAction.org are investigating these Omron blood pressure monitors in light of customer complaints that the devices are inaccurate. Specifically, they’re looking into whether a class action lawsuit can be filed against Omron for potentially misleading customers, many of whom rely on the medical devices to manage health conditions.
- How Could a Lawsuit Help?
- If successful, a class action lawsuit could help customers get back some of the money they spent on Omron blood pressure monitors and potentially force the company to ensure that the medical devices are accurately represented.
Attorneys working with ClassAction.org want to hear from anyone who purchased an Omron Platinum blood pressure monitor (model BP5450) within the past three years.
They’re looking into whether the blood pressure monitors are falsely advertised in light of complaints that the devices, which claim to be accurate within +/- 3 mm Hg, produce widely inaccurate readings. Indeed, one reviewer stated that the Omron Platinum monitor’s readings were “consistently 10+ mm Hg off,” making the device essentially useless.
The attorneys are now investigating whether a class action can be filed against Omron – but they first need to hear from more people who bought the blood pressure monitors.
Online Reviewers Question Omron Monitors’ Accuracy
Customers who reviewed the Omron Platinum blood pressure monitor (model BP5450) on Amazon have reported that the device’s readings have been widely inaccurate and unreliable.
One Amazon review detailed a customer’s own testing of the device, which involved taking nine consecutive measurements one minute apart. Over the less than 20 minutes it took to collect these readings, the consumer’s systolic blood pressure ranged from 144 to 164, according to the review. The individual wrote that the Omron Platinum blood pressure monitor was “not anywhere close to the stated +/-3 mm Hg accuracy.”
Another reviewer who brought the Omron Platinum blood pressure monitor to a doctor’s appointment said the monitor’s readings were as much as 91 points higher than the doctor’s machine and manual readings. The review stated that based on the Omron monitor’s readings, the consumer “should be in the hospital or dead” and warned others against relying on the device’s accuracy “for any health related [sic] issues.”
Indeed, many reviewers expressed concerns that they had been overmedicating based on their Omron blood pressure monitor’s potentially inaccurate readings.
Below is a sampling of other reviews that question the Omron Platinum monitor’s accuracy [sic throughout]:
I am not impressed with this bp monitor. I have low blood pressure and this machine is reading at high bp. I can take my bp reading several times in a row and the readings are wildly different.”
— Aussie Mom, Amazon.com
I wouldn’t use until you can verify the accuracy. Reads 15 high on the upper number and 9 on the lower when comparing to a calibrated unit at the doctors office. Not good when you’re trying to get BP under control and run the risk of being over medicated due to the inaccurate readings.”
— Amazon Customer, Amazon.com
Confirmed with my doctor that this Omron machine reads about 10 points high compared to their machine and the manual blood pressure reading done in the doctors office. Omron states this is within their tolerances but the documentation doesn’t state that. I do not find this acceptable and would not recommend.”
— Coastalcool, Amazon.com
This monitor showed that my blood pressure was 125/55, but the doctor’s office monitor said 140/56. Both monitors were used at the same time, in the doctor’s office. Try a different brand. This isn’t as accurate as the ratings state.”
— Jane W., Amazon.com
My cardiologist asked me to take my BP twice a day and report back to him. I bought the best OMRON consumer level monitor in order to do this. He added another BP med to my other three based on the numbers I reported to him. He then asked me to bring the monitor in to see if it was properly calibrated. I was shocked and upset to learn that the numbers were totally off (by a lot!!!). I cannot recommend this monitor.”
— Karen Lynn A., Amazon.com
Why buy something that [is] inaccurate? Omron model #BP5450: This machine is consistently reading 20 points above. It’s very scary to see my BP is at 170s when it’s not. My doctor and nurses manually measured by BP over the past few months and it consistently read 20+ points over.”
— mgoh, Amazon.com
Omron Blood Pressure Monitor Accuracy Test
Some reviewers noted that the Omron Platinum’s user manual states the device is accurate within a range of +/- 3 mm Hg, and the product listing represents that the monitor “meets the Validated Device Listing (VDL) for Clinical Accuracy as determined through an independent review process.”
However, a study commissioned by Omron from researchers at Northwestern University indicates that the Omron Platinum BP5450 is accurate within a range of +/- 3.6 mm Hg for diastolic pressure – and that the results were much more inaccurate for users with a larger arm circumference.
How Could a Lawsuit Help?
If filed and successful, a class action lawsuit may be able to help customers get back some of the money they spent on their Omron blood pressure monitors. It could also require Omron to ensure that its devices are accurate or are not falsely advertised.
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