Description of Event or Problem · 0
IT WAS REPORTED THAT AN ILET USER EXPERIENCED HYPERGLYCEMIA AFTER EATING WITHOUT ANNOUNCING THE MEAL TO THE SYSTEM, WHILE ALSO NOTING LOW REMAINING INSULIN IN THE CARTRIDGE AND CONCERN ABOUT ACCELERATED SUPPLY USE; THE USER REPORTED NO VISIBLE ISSUES WITH THE INFUSION SET TUBING OR CARTRIDGE AND WAS USING A CD INFUSION SET FROM LOT 6013573. SYMPTOMS INCLUDED FEELING PANICKY WITH A RECORDED BLOOD GLUCOSE OF 355 MG/DL. OUTCOMES INCLUDED REDUCTION OF BLOOD GLUCOSE TO 175 MG/DL AND SYMPTOM IMPROVEMENT FOLLOWING FOLLOW-UP GUIDANCE AND EDUCATION, AND REPLACEMENT CARTRIDGES AND TUBING WERE SHIPPED. INVESTIGATION INCLUDED TROUBLESHOOTING WITH THE USER AND EDUCATION REGARDING MEAL ANNOUNCEMENTS AND SUPPLY MANAGEMENT. INVESTIGATION OF THIS CASE REVEALED NO DEVICE MALFUNCTION COULD BE CONFIRMED AND THAT THE EVENT WAS CONSISTENT WITH MISSED MEAL ANNOUNCEMENT LEADING TO HYPERGLYCEMIA. IT WAS CONCLUDED THAT THE CAUSE OF HYPERGLYCEMIA WAS UNCLEAR, WITH USER-RELATED FACTORS LIKELY CONTRIBUTORY AND NO CONFIRMED DEVICE FAILURE. THE DEVICE HAS NOT BEEN RETURNED. IF IT IS RETURNED, IT WILL BE EVALUATED, AND A SUPPLEMENTAL REPORT WILL BE FILED.