On Thursday, the FDA notified the public of a recall initiated by Abbott Diabetes Care Inc. of three lots of its FreeStyle Libre 3 sensor, which is a component of the company’s FreeStyle Libre 3 Continuous Glucose Monitoring System. The company says that the implicated sensor occasionally provides elevated glucose readings that are inaccurate, which can pose a health risk to patients with diabetes.
Abbott Diabetes Care Inc. announced the recall on July 24, 2004, providing a UDI of UDI-DI 00357599818005 and a Model Number of 72081-01. The lot numbers included in the recall are T60001948, T60001966, and T60001969. The company clarified that the recall does not apply to the FreeStyle Libre 3 Continuous Glucose Monitoring System itself, but only to the sensor component.
Patients with a prescription can use the FreeSyle Libre 3 Continuous Glucose Monitoring System for nonstop glucose monitoring, which can then provide patients and their medical team with the data needed to formulate an effective treatment plan. In products with a faulty sensor, the monitoring system can provide inaccurate glucose readings. If patients or health care professionals administer treatment based on an inaccurate glucose reading, serious injury or death can occur. The FDA says the possible adverse health consequences might include “severe low blood sugar (hypoglycemia) which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death.”
Abbott Diabetes Care Inc. has received two reports of injury in connection to the FreeStyle Libre 3 sensor from the identified lots. The company requests that customers and distributors in possession of an affected sensor immediately stop use of the sensors and dispose of them. Customers can visit Home | FreeStyle – Abbott (freestyleconfirm.com) to ensure their serial number is included in the recall and to request a replacement sensor.
The company also urges users of the FreeStyle Libre 3 Continuous Glucose Monitoring System to regularly compare symptoms with their glucose readings. If a reading seems inaccurate, patients should double-check glucose levels with an alternate device as a safety precaution.
Patients or distributors with questions about the recall can contact customer service for Abbott Diabetes Care Inc. at 1-833-815-4273.
If you or a loved one has experienced an adverse health event caused by a faulty component in a glucose monitoring system or any other medical device, you deserve justice and fair compensation. The attorneys at TruLaw are personally committed to preserving consumer safety and holding negligent parties responsible for the consequences of a faulty medical device. To learn more about how we can support you through this time, contact us or take our free Instant Case Evaluation ℠.