Description of Event or Problem · 0
IT WAS REPORTED THAT THE USER RECEIVED A CGM SENSOR EXPIRATION ALERT AND REQUIRED ASSISTANCE REPLACING THE SENSOR; DURING GUIDANCE, THE USER HAD DIFFICULTY NAVIGATING THE PUMP MENUS AND REPEATEDLY READ ITEMS FROM THE CGM ALERTS SCREEN, MISINTERPRETING THE WORD ¿HIGH¿ ON THAT MENU AS A HIGH GLUCOSE READING WHILE NO SENSOR WAS CONNECTED. THE USER ALSO BELIEVED A SUPPLY CHANGE WAS DUE, BUT REVIEW CONFIRMED ADEQUATE INSULIN ON BOARD AND THAT ROUTINE CHANGE WAS PLANNED FOR THE NEXT MORNING. THE USER EXPERIENCED A LOW GLUCOSE EVENT TO 70 MG/DL EARLIER IN THE DAY, SELF-TREATED WITH ORAL GLUCOSE, AND REPORTED HEARING ONLY ONE ALERT TONE, WHICH WAS CONSISTENT WITH A PREDICTIVE LOW NOTIFICATION AND RECOVERY WITHOUT SYMPTOMS. SYMPTOMS INCLUDED HYPOGLYCEMIA WITHOUT REPORTED CLINICAL SEQUELAE. OUTCOMES INCLUDED SUCCESSFUL SENSOR REPLACEMENT INITIATION AND USER EDUCATION ON MENU NAVIGATION, ALERT SOURCES, AND SUPPLY STATUS. INVESTIGATION INCLUDED REVIEW OF PUMP SETTINGS AND CONFIRMATION THAT ALARMS WERE ENABLED AND SET TO HIGH VOLUME, AS WELL AS ASSESSMENT OF USER-REPORTED DEVICE BEHAVIOR DURING CGM ALERT NAVIGATION. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR, WITH CONTRIBUTORY USER INTERFACE CONFUSION AND NO CONFIRMED DEVICE MALFUNCTION. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.