Khaberni - Multinational healthcare company Abbott has recalled millions of blood glucose measuring sensors, models FreeStyle Libre 3 and FreeStyle Libre 3 Plus.
This follows the discovery of a technical defect that could lead to inaccurate readings associated with serious health risks, including seven deaths and 736 injuries (57 of these in the United States).
The company reports indicate that the malfunction arose from a single production line out of several manufacturing lines for these sensors. Approximately three million defective sensors were distributed within the United States, plus millions more in many countries, including Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, the Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland, and the United Kingdom.
A large number of diabetes patients rely on these devices for accurate monitoring of glucose levels, as unrealistically high readings could lead to the neglect of treating hypoglycemia, which poses a risk of severe hypoglycemia. Conversely, falsely low readings may result in excessive insulin doses, leading to severe drops in sugar levels.
Failure to detect actual increases in glucose levels could result in diabetic ketoacidosis, a life-threatening complication.
The company explained that the sensor's operation relies on inserting a thin thread covered with a special enzyme under the skin to measure glucose in the interstitial fluid, converting glucose concentration into an electric current measured electronically and transmitting the readings to users' phones.
Abbott highlighted that samples taken from the affected production line showed inaccurately low readings and stressed that prolonged reliance on them could lead to incorrect treatment decisions, such as overconsumption of carbohydrates or skipping insulin doses, potentially causing serious injuries or even death, in addition to long-term complications including nerve damage, kidney diseases, and cardiovascular issues.
The company confirmed that it has identified and resolved the source of the malfunction, noting that it continues to produce the Libre 3 and Libre 3 Plus sensors to meet new and replacement orders without expecting a significant shortfall in supplies.
Recall-affected models:
FreeStyle Libre 3:
Model numbers: 72081-01 and 72080-01.
Unique device identifiers: 00357599818005 and 00357599819002.
FreeStyle Libre 3 Plus:
Model numbers: 78768-01 and 78769-01.
Unique device identifiers: 00357599844011 and 00357599843014.
