Wow, LifeScan's OneTouch Verio IQ meter just barely hit market in the U.S., and we got word today that all meters across the country and across Canada are being "voluntarily removed and replaced" by the company, due to an error that can cause the meter to shut down when a user accesses the stored test results.
VerioIQ is LifeScan's new smart meter, billed as "the first meter ever that automatically alerts you to patterns... and provides guidance on what actions can be taken to enhance glucose control." The guidance, btw, is something you have to look up in a booklet that comes with the meter, LifeScan's "Test Smart Pattern Guide — a quick reference tool to help people living with diabetes interpret and resolve high and low patterns."
According to LifeScan, if the shutdown error occurs: "When the product is turned back on, the meter enters the 'set up' mode and requires the user to confirm the date and time settings before being able to test again. Fortunately, this issue has no effect on the accuracy of test results or functions such as onscreen pattern notifications, averages, result tagging, or downloading -- and no data is lost. However, if the user does not confirm all settings, testing is not possible. Therefore, treatment may be delayed or a treatment decision may be made in the absence of a glucose result."
You can read the company's official letter to customers (PDF) here.
We weren't able to access any stats, but imagine the number of customers affected is low in the U.S., since this new meter was just approved by FDA last month.
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Essentially, if you have a Verio IQ meter, all you have to do is call LifeScan Customer Service at 1-888-567-3003 to receive a replacement meter at no charge. The package contains instructions on how to return the faulty meter to them.
Note that they're making a big point of emphasizing that while you wait for your replacement meter, "you can continue to test with confidence with your current OneTouch VerioIQ meter" (umm, just don't try to access your results records, I guess?). They're also flagging the fact that the OneTouch Verio Test Strips are "not impacted by this issue."