Abbott, a global leader in healthcare, has launched an extensive recall of its continuous glucose monitoring sensors in over a dozen countries. The recall is due to concerns about potentially deadly inaccuracies in blood sugar readings.

This week, Abbott announced the recall of specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. These devices are used by individuals with type 1 and type 2 diabetes to monitor blood sugar levels. The company identified that the sensors could provide readings that are inaccurately low, a flaw linked to seven fatalities and 736 serious health issues, including 57 incidents in the United States.

In the U.S. alone, around three million faulty sensors were distributed, with additional units sold in countries such as Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, the Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland, and the United Kingdom.

Accurate blood sugar readings are crucial for diabetics to maintain their health. Incorrectly high readings pose a significant risk. If a diabetic’s sensor suggests their glucose is at a normal or elevated level when it is actually low, they might not consume the fast-acting carbohydrates needed, leading to a hazardous drop in blood sugar, known as hypoglycemia.

Conversely, a reading that inaccurately indicates low blood sugar can prompt someone to take extra insulin unnecessarily, potentially causing their actual blood sugar to plummet to dangerous levels.

Failure to recognize and treat true high blood sugar can allow glucose levels to rise into the danger zone of diabetic ketoacidosis, a life-threatening complication.

The sensor issue stemmed from a single production line among many that make the Libre 3 and Libre 3 Plus sensors, according to Abbott. Anyone with an impacted device should stop using it, Abbott and the FDA said.

Abbott added: ‘The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruptions.’

Inaccurate glucose readings pose direct risks. A falsely high reading may cause a diabetic to miss a dangerous low reading, while a falsely low reading can prompt an insulin overdose and severe hypoglycemia (stock)

Roughly 1.8million Americans have type 1 diabetes and 34million have type 2. Around 2.5million of them use glucose monitors to keep track of their blood sugar peaks and valleys. 

To use the sensors, a tiny, flexible filament coated with a special enzyme is inserted just under the skin in the interstitial fluid, not blood.

Glucose from the interstitial fluid diffuses into the sensor. The enzyme glucose oxidase catalyzes a reaction between glucose and oxygen in the fluid, producing gluconic acid and a small electrical current.

The sensor’s electronics measure this tiny electrical current. The strength of the current is directly proportional to the glucose level, in which more glucose equates to a stronger current.

People can monitor their levels on their smartphones. 

According to Abbott, sampling of products from a single production line gave inaccurately low readings.

The company said: ‘If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses.

‘These decisions may pose serious health risks, including potential injury or death, or other less serious complications.’

The above graph shows estimates for global diabetes cases. It is predicted that the number of people with the condition will more than double by the year 2050 compared to 2021

According to Abbott, seven people have reportedly died due to inaccurate readings from the devices, while hundreds, including 57 Americans, have been injured in some way

A person might eat more sugar than they need, causing their blood sugar to spike dangerously high. Or, they might skip or delay their insulin dose because they’re scared of going low, which also lets their blood sugar rise too high.

Over time, these mistakes from faulty data can lead to severe long-term health damage, including nerve damage, kidney disease and cardiovascular risk, and increase the risk of emergencies, such as seizures, loss of consciousness and coma.

The company did not elaborate on the kinds of injuries, including the 57 reported in the US, that people suffered in relation to the faulty sensors.

Abbott added: ‘Abbott has identified and resolved the cause of the issue, which relates to one production line among several that make Libre 3 and Libre 3 Plus sensors.

‘The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruptions.’

The model numbers for the affected FreeStyle Libre 3 sensors are 72081-01 and 72080-01, and the unique device identifiers are 00357599818005 and 00357599819002.

The model numbers for the affected FreeStyle Libre 3 Plus sensors are 78768-01 and 78769-01, and the unique device identifiers are 00357599844011 and 00357599843014.

Abbott has created a site that allows people to see if their monitors are affected.