LINGO GLUCOSE SYSTEM

Description of Event or Problem

AN ERROR MESSAGE ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. A CUSTOMER REPORTED ENCOUNTERING UNKNOWN ERROR MESSAGE WITH THE ADC DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED IRRITABILITY, CONFUSION AND LOSS OF CONSCIOUSNESS. THE CUSTOMER REGAINED CONSCIOUSNESS AND WAS ABLE TO SELF-TREAT WITH FOOD. IT IS UNKNOWN IF THE CUSTOMER RECEIVED THIRD PARTY TREATMENT. 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.