Warning Label

mr-yuk-300x300It’s no secret how I feel about blood glucose meter accuracy: without it, I’m dead.

Blood sugar monitoring devices have become the linchpin in diabetes care. The number shown on a screen is what determines how much insulin I take, whether or not I eat 15 grams of carbohydrates, and in conjunction with a continuous glucose monitor, whether my blood sugar is going up or down. In the days before home blood glucose testing, it was a total shot in the dark as to whether you were “in range”, because urine testing wasn’t accurate. (Then again, neither was the insulins that were used.)

That’s why I’m a vocal advocate for the StripSafely campaign, bringing awareness of the need to tighten standards and help those who have sway over accuracy and accuracy enforcement of blood glucose testing systems. Since it began this summer, StripSafely has made an impact with the FDA and we are continuing to work with those who want to help ensure we get the accuracy we deserve.

A First For The FDA

When a device manufacturer wishes to bring a blood glucose monitoring system to market, it has to submit paperwork to the FDA showing that it’s met the requirements and standards for the device in question. If it already has a device approved, it’s an easier process with less paperwork, basically showing a comparison to the existing device and highlighting any differences.

A recent approval for a device manufacturer came with something never seen in the diabetes device market: a warning label on every test strip box insert, user manual, and meter box. (I’ve redacted the name of the meter because, you know, bears.)

CAUTION

Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality. The {meter name redacted} is less accurate than most other blood glucose meters sold today. The {meter name redacted} does not provide reliable accuracy readings beyond the following margins of error:

For glucose concentrations < 75 mg/dL, 95% of the results shall be within ± 15 mg/dL.

For glucose concentrations > 75 mg/dL, 95% of the results shall be within ± 20%.

DO NOT USE THE {meter name redacted} TO CALCULATE INSULIN DOSAGES.
DO NOT USE THE {meter name redacted}TO CALIBRATE CONTINUOUS GLUCOSE MONITORS
And on every test strip box:
The {meter name redacted} is less accurate than most other blood glucose meters sold today.
DO NOT USE THE {meter name redacted} TO CALCULATE INSULIN DOSAGES.
DO NOT USE THE {meter name redacted}TO CALIBRATE CONTINUOUS GLUCOSE MONITORS
*Want to learn more? Visit this post at StripSafely: Thanks, FDA.

Why Would You Use A Less Accurate Meter?

Goodness gracious. So, for any person with diabetes who uses insulin (or may have to use insulin in the future, for those Type 2s currently on meds or on lifestyle modifications), you are cautioned by the FDA not to use this product. Why even bother purchasing it when you have other options? If you know that something is not accurate – and that accuracy does matter, why even bring it to market?

Money. Yeah. The meter and the strips are cheap, but what’s the real cost?

Health. Inaccurate blood glucose reading can result in wrong dosing decisions. It can result in hospitalizations. It can result in death.

I’m obviously not the target market for this meter, but I’m concerned that those who are looking to save on healthcare costs (or those who are under Medicaid or Medicare and are bound by whatever CMS approves), will not have a choice in whether or not they have to use it.

Mr. Yuk

The warning label is my most favorite holiday gift from the FDA so far. (Perhaps I’ll make a suggestion to the FDA that the warning label should have a Mr. Yucky face on it, which stood for poison when I was a kid.) I’m hoping that the manufacturer in question recognizes that this is an opportunity to either fix the accuracy of their product – or cut their losses and not bring it to the U.S. market.

Based on past history, however, the company may well just suck it up and stick the warning labels on their product, all for the sake of making a buck. And to that, I say this:

People with diabetes, we’ve got the FDA and StripSafely on our side.

 

Game on.

2 comments

  1. Andy

    As a participant on behalf of the manufacturer in the 510k application referenced, I can assure you that the FDA has heard the issues raised by StripSafely and other patient advocates. I am also confident that the FDA has and will always require appropriate standards for consumer safety. Patient Advocates like yourselves, along with professionals, help to focus the issues and clarify expectations.
    The product manufacturers and distributors have also heard the same concerns, and are working to address them. The process takes some time, and results aren’t achieved overnight. The 510k at issue was submitted in early 2012. Throughout the process the FDA raised questions about accuracy, as it should. The manufacturer considered withdrawing the 510k, but chose to propose cautionary statements on all of the labeling, obtain the 510k, but NOT to market the product. Upon receiving notice of clearance, the Company immediately notified the FDA of its decision not to market the product. By doing this, the Company can conduct further R&D to develop a state of the art product, with accuracy and precision performance that you demand and expect, and, if achieved, to resubmit it to the FDA for an amendment to the 510k. The amendment process would likely take substantially less time than that required if the Company had withdrawn its submission. If acceptable accuracy standards are not achieved for this meter and test strip combination, then the Company will not market the product.
    I can assure you that the FDA and the manufacturer have heard your voices and understand your concerns. StripSafely is having an impact, and bringing change for the better.

  2. Pingback: Around the Diabetes Blogosphere: Bye, Bye, 2013! : DiabetesMine: the all things diabetes blog

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