FreeStyle Libre 3 Plus

Description of Event or Problem

A high readings issue with the Abbott Diabetes Care (ADC) device was reported. The customer received a high sensor scan result of 159 mg/dL and noted a horizontal trend arrow which indicates glucose is changing slowly (less than 1 mg/dL per minute). On (b)(6)2026, the customer experienced feeling unwell prior to performing a finger prick test and subsequently lost consciousness shortly thereafter. Reported symptoms included passing out, nausea, clamminess, sweaty shoulder blades, sensor site pain. After an unspecified amount of time, the customer reported that a low glucose result of 76 mg/dL occurring approximately 23 minutes after the event. The customer was unable to self-treat and no third-party treatment reported. There was no report of death or permanent impairment associated with this event.

Additional Manufacturer Narrative

The product has been requested back for investigation and the customer agreed to return the device. A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained. All pertinent information available to Abbott Diabetes Care has been submitted.