Case Info
Abbott FreeStyle Libre Monitoring Device May Give Inaccurate Blood Glucose Reading
Medical device maker Abbott Diabetes Care, Inc., has issued a voluntary recall for some of its FreeStyle Libre 3 blood glucose devices. The company has acknowledged that the glucose sensor devices may give false results of high or low blood glucose levels, prompting higher or lower than needed doses of insulin which may cause serious injury.
Abbott continuous glucose monitor (CGM) devices which have been affected by the recall include:
- Abbott FreeStyle Libre 3 Sensor
Seven deaths and 736 serious injuries associated with the devices have been reported.
For a full list of impacted model numbers, see here: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-glucose-monitor-sensor-issue-abbott-diabetes-care
Overuse of Insulin May Result in Serious Injury
Inaccurate results given by the affected FreeStyle Libre blood glucose monitoring may lead to higher or lower than medically necessary insulin dose calculations. Administration of too much insulin may result in low blood glucose levels and serious injuries.
Serious injuries caused by low glucose levels may include:
- Central nervous system changes, resulting in seizures or falls
- Heart Arrhythmias
- Loss of consciousness
- Coma
- Permanent brain or neurological damage
- Death
At least seven deaths and 736 serious injuries have been linked to low blood glucose levels reported by an Abbott FreeStyle Libre 3 CGM.
People who were injured by an Abbott FreeStyle Libre 3 or Abbott FreeStyle Libre 3 Plus CGM for monitoring their blood sugar levels may have received false reports of low blood glucose levels may be eligible for compensation.