Abbott warns that a small number of FreeStyle Libre 3 sensors may provide inaccurate readings
Abbott, a leader in diabetes technology with one of the largest lines of continuous glucose monitors, announced this week that it is issuing a voluntary correction for medical devices some of his FreeStyle Libre 3 sensorsafter tests by the company showed they could give false readings for high blood sugar levels.
The affected sensors include only 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 U.S., the company said in a statement, and the affected sensors were reportedly distributed in 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) and take insulin if needed. Inaccurate blood sugar readings can affect 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 to CNET, an Abbott spokesperson said the company estimates the issue affects less than 1% of FreeStyle Libre 3 users in the U.S., but the company encourages all customers to check their sensor serial number to be sure.
Which FreeStyle Libre 3 sensors are affected?
The correction only affects 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 on the bottom of the sensor kit box. If your lot number matches one of the three listed above, enter the serial number is also stated on the packaging to confirm whether it has been affected.
If you no longer have the package or kit, or if you are already wearing the sensor, There are several ways you can check your serial number to see if it has been compromised. Abbott says you can find the sensor serial number on the reader through to settings menuSelecting system status and then system information. 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 the Abbott website to get your free replacement.
What to do if you have a compromised sensor
If you enter your serial number and it turns out that you are experiencing this issue, you will need to enter your contact information so that Abbott can send you a new one at no charge.
If you have a compromised sensor, Abbott says you should discontinue use and discard it. The company also advises consumers to perform a fingerstick test with a blood glucose meter if you “experience symptoms that are inconsistent with the sensor glucose reading” or if you “suspect the reading is inaccurate.” There is 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 any questions about your CGM or sensor, or what to do if your sensor is compromised.
“We sincerely regret the disruption this may cause to our customers,” Jared Watkin, executive vice president of Abbott’s diabetes care business, said in the statement. “We are actively working with the U.S. Food and Drug Administration and distributors, and are providing information to affected customers, who will receive free replacements as soon as possible.”