Health and Me

Itisha Arya

FDA Reports Seven Deaths, 736 Serious Injuries Tied To Faulty Glucose Monitoring Devices

glucose monitoring device

Malfunctioning glucose sensors made by <span>Abbott Diabetes Care</span> have been tied to more than seven hundred serious medical events and seven possible deaths, according to updates from both Abbott and the <span>Food and Drug Administration</span> (<span>FDA</span>). The company issued a public notice on November 24 and sent letters to those who may be affected, explaining that it had begun a “medical device correction” for select <span>FreeStyle Libre</span> 3 and FreeStyle Libre 3 Plus sensors. 

On December 2, the FDA released an early safety communication, which is the type of alert shared when a product is corrected or removed because of a significant risk before the agency can determine whether an official recall is necessary.

<h2>FDA: Seven Deaths Possibly Linked To Malfunctioning Glucose Monitors</h2>

Some FreeStyle Libre 3 sensors may show falsely low blood sugar levels, which can lead people with diabetes to make treatment choices that are not appropriate for their actual condition. When someone’s glucose appears low, they might delay their insulin dose or skip it altogether, or they may eat more carbohydrates in an effort to raise their levels, as noted by USA Today.

When treatment decisions are based on incorrect readings, blood sugar can quickly become unstable. Poor glucose control can result in dangerous medical complications, including injury or even death. Problems linked to mismanaged diabetes can include diabetic ketoacidosis, heart issues, stroke, kidney damage, nerve and eye problems, and a higher chance of infection.

USA Today reports that the issue affects nearly three million Libre 3 and Libre 3 Plus sensors sold in the United States, and Abbott estimates that roughly half of them have already been used or have expired. Worldwide, the company has received 736 reports of severe adverse events (57 in the U.S.) and seven reports of deaths (none in the U.S.) that may be associated with this problem.

<h2>Which <span rel="noindex">Abbott Diabetes Care Products Are</span> Impacted?</h2>

Only specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring Systems are affected. The FreeStyle Libre 3 handheld reader and mobile app are working normally.

No other Libre devices (FreeStyle Libre 14-day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or the <span>FreeStyle Libre Pro</span> sensors) or Abbott biowearable products are involved.

<ul><li>Model Numbers: 72081-01, 72080-01</li><li>Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002</li></ul>

<ul><li>Model Numbers: 78768-01, 78769-01</li><li>Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014</li></ul>

The serial number for a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor is available in the app or reader, and it is also printed on the label at the bottom of the sensor applicator or on the carton. Consumers who are wearing a sensor that has been confirmed as part of the affected group should stop using it at once and safely discard it.

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Malfunctioning glucose sensors made by Abbott Diabetes Care have been tied to more than seven hundred serious medical events and seven possible deaths, according to updates from both Abbott and the Food and Drug Administration (FDA). The company issued a public notice on November 24 and sent letters to those who may be affected, explaining that it had begun a “medical device correction” for select FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. On December 2, the FDA released an early safety communication, which is the type of alert shared when a product is corrected or removed because of a significant risk before the agency can determine whether an official recall is necessary.FDA: Seven Deaths Possibly Linked To Malfunctioning Glucose MonitorsSome FreeStyle Libre 3 sensors may show falsely low blood sugar levels, which can lead people with diabetes to make treatment choices that are not appropriate for their actual condition. When someone’s glucose appears low, they might delay their insulin dose or skip it altogether, or they may eat more carbohydrates in an effort to raise their levels, as noted by USA Today.When treatment decisions are based on incorrect readings, blood sugar can quickly become unstable. Poor glucose control can result in dangerous medical complications, including injury or even death. Problems linked to mismanaged diabetes can include diabetic ketoacidosis, heart issues, stroke, kidney damage, nerve and eye problems, and a higher chance of infection.USA Today reports that the issue affects nearly three million Libre 3 and Libre 3 Plus sensors sold in the United States, and Abbott estimates that roughly half of them have already been used or have expired. Worldwide, the company has received 736 reports of severe adverse events (57 in the U.S.) and seven reports of deaths (none in the U.S.) that may be associated with this problem.Which Abbott Diabetes Care Products Are Impacted?Only specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring Systems are affected. The FreeStyle Libre 3 handheld reader and mobile app are working normally.No other Libre devices (FreeStyle Libre 14-day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or the FreeStyle Libre Pro sensors) or Abbott biowearable products are involved.FreeStyle Libre 3 SensorModel Numbers: 72081-01, 72080-01Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002FreeStyle Libre 3 Plus SensorModel Numbers: 78768-01, 78769-01Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014The serial number for a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor is available in the app or reader, and it is also printed on the label at the bottom of the sensor applicator or on the carton. Consumers who are wearing a sensor that has been confirmed as part of the affected group should stop using it at once and safely discard it.