Faulty medical devices can have fatal consequences.
Early Alert Issued After 736 Injuries, 7 Deaths Linked to Faulty Glucose Monitor
Early Alerts are issued by the FDA when a medical device poses a serious health risk but does not yet meet the criteria for a formal recall.
According to a KSAT News report, the FDA issued an early alert for specific FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor devices from Abbott Diabetes Care.¹ The sensors may deliver inaccurate glucose readings, which can lead to improper insulin dosing and other medical complications. As of November 24th, Abbott reported 736 injuries and seven deaths linked to this issue.
Affected Product Details (from the FDA)²
The FDA confirmed that Abbott has notified distributors, health care providers, and customers to remove certain glucose monitor sensors from use:
FreeStyle Libre 3 Sensor
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Model Numbers: 72081-01, 72080-01
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UDI-DI: 00357599818005, 00357599819002
FreeStyle Libre 3 Plus Sensor
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Model Numbers: 78768-01, 78769-01
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UDI-DI: 00357599844011, 00357599843014
You can check your sensor’s serial number using the FreeStyle app or reader. Consumers can verify whether their device is affected at:
No other Abbott products — including readers or the mobile app — are affected.
What to Do If Your Sensor Is on the List
If your sensor is identified as potentially affected:
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Stop using it immediately and dispose of it as instructed.
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Request a free replacement by selecting “Confirm Sensor Serial Number” on www.FreeStyleCheck.com and entering your serial number.
The site will prompt you to enter your contact details so Abbott can ship a replacement at no cost.
Did You Know?
The FDA receives over two million medical device reports each year involving suspected device-related deaths, serious injuries, or malfunctions.³
Injured by a Faulty Medical Device? Here’s What to Do
Texas has one of the highest populations of medical device users in the country, making alerts like this especially relevant to local patients. Medical devices are designed to keep patients safe and stable. But when a sensor, monitor, or implant malfunctions, the consequences can be severe — especially for individuals who rely on accurate readings to manage chronic conditions like diabetes.
If you’re injured by a defective medical device, here’s what to do to protect your health and your legal rights:
1. Seek Medical Care Immediately
If your device gave inaccurate readings or caused dangerous symptoms, get medical attention right away. Not only does this protect your health, but it also documents your injuries — something that becomes crucial if you decide to pursue a claim later.
2. Preserve the Device and Documentation (If Safe to Do So)
Do not throw away the device unless the FDA or manufacturer specifically instructs you to do so.
If it’s safe, keep:
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The device itself
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The packaging
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The instruction manual
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Any receipts or proof of purchase
These items may serve as evidence in a product liability claim.
For the FreeStyle Libre sensors listed in the alert, the FDA has advised consumers to stop using the affected sensors and discard them — but be sure to record the serial number and take photos before disposal.
3. Report the Problem to the FDA
Anyone can file a report about an unsafe device through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program. Reporting helps regulators track patterns, issue alerts sooner, and determine whether a recall is necessary.
4. Document Your Symptoms and Costs
Keep a written record of:
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Symptoms experienced
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Dates and times of abnormal device readings
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Hospital or doctor visits
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Medication adjustments
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Missed work days
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Any out-of-pocket expenses
Detailed documentation strengthens your case.
5. Speak With a Personal Injury Attorney
Medical device claims can be complex. Multiple parties — including manufacturers, distributors, and health care providers — may share liability. An attorney can help determine whether the product was defective and what compensation you may be entitled to, including:
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Medical bills
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Lost wages
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Long-term complications
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Pain and suffering
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Wrongful death damages in fatal cases
Injured by a Faulty Medical Device in Texas? Call Shaw.
The FreeStyle Libre early alert shows how quickly a device malfunction can put patients at risk. If a defective medical device has harmed you or someone you love, you don’t have to navigate the aftermath alone.
The attorneys at Carabin Shaw have decades of experience handling defective product and medical device claims throughout Texas. We can help you understand your rights and next steps.
Call Shaw at 800-862-1260 today for a free, confidential consultation.