Abbott, a leader in diabetes tech with one of the biggest lines of continuous glucose monitors, announced this week that it's issuing a voluntary medical device correction for some of its FreeStyle Libre 3 sensors, after testing by the company found they may give incorrect high blood sugar readings.
The affected sensors includes just three lots of the FreeStyle Libre 3 sensors -- not the Freestyle Libre app, reader or any of Abbott's other product lines. It also only affects customers in the US, the company said in a statement, and affected sensors would've been distributed during the first half of May.
People with diabetes use CGMS and sensors like the FreeStyle Libre 3 to track their blood glucose (also called blood sugar) levels and medicate with insulin as necessary. Incorrect blood sugar readings may impact medication decisions, posing a health risk. If you have one of the affected sensors, which Abbott says is a "small subset" of the company's Libre 3 product, you should stop using it and contact Abbott for a new one.
In an email response to CNET, a spokesperson for Abbott said the company estimates it may impact less than 1% of FreeStyle Libre 3 users in the US, but the company is encouraging all customers to check the serial number of their sensor to be sure.
Which FreeStyle Libre 3 sensors are affected?
The correction includes just three lots of Abbott's FreeStyle Libre 3 sensors. The lot numbers are:
- T60001948
- T60001966
- T60001969
If you still have the sensor package, the lot number should be printed at the bottom of the sensor kit carton. If your lot number matches one of the three listed above, punch in the serial number also listed on the package to confirm whether it's affected.
If you don't have the package or kit anymore, or you're already wearing the sensor, you can check for your serial number a couple of different ways to see whether it's been affected. Abbott says you can find the sensor serial number on the reader by going to settings menu, selecting system status and then system info. To find the serial number on the FreeStyle Libre 3 app, go to main menu and then the about screen.
However you find the serial number, confirm it on Abbott's website to get your free replacement.
The affected FreeStyle Libre 3 sensors were distributed during the first half of May this year. To check if yours is included, look for the serial number on the package, app or reader, and then enter the serial number on Abbott's website.
AbbottWhat to do if you have an affected sensor
If you enter your serial number and it's confirmed to be affected, you should enter your contact information for Abbott to send you a new one at no extra cost.
If you have an impacted sensor, Abbott says you should stop using it and dispose of it. The company is also directing consumer to use a fingerstick test using any blood glucose meter if you're "experiencing symptoms that do not match the sensor glucose reading," or if you "suspect the reading may be inaccurate." There's a built-in blood glucose meter in the FreeStyle Libre 3 reader that can be used to check glucose at any time.
As always, you should contact your doctor if you have questions about your CGM or sensor, or what to do if your sensor has been affected.
"We sincerely regret the disruption this may have on our customers," Jared Watkin, executive vice president of Abbott's diabetes care business, said in the statement. "We're actively working with the U.S. Food and Drug Administration and distributors, as well as providing information to affected customers, who will receive replacements at no charge as quickly as possible."
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.