Description of Event or Problem · 0
IT WAS REPORTED THAT THE USER RECEIVED A LIBRE 3+ SENSOR ERROR FOLLOWED BY A SENSOR EXPIRED ALERT, REMOVED THE SENSOR, AND INADVERTENTLY ATTEMPTED TO START A NEW SENSOR WITH AN APPLICATOR THAT CONTAINED NO SENSOR, WHICH RESULTED IN THE ILET ENTERING BG RUN MODE AND PROMPTING FOR PERIODIC FINGERSTICK ENTRIES; THE USER MANUALLY ENTERED FINGERSTICK READINGS, INCLUDING 141 MG/DL AND LATER 230 MG/DL, WITH EDUCATION PROVIDED ON DISMISSING ALARMS AND ENTERING BG WITHIN REQUIRED INTERVALS. SYMPTOMS INCLUDED HYPERGLYCEMIA PEAKING AT 230 MG/DL. OUTCOMES INCLUDED CONTINUED INSULIN DOSING VIA BG RUN MODE WITH USER-ENTERED FINGERSTICK VALUES AND RESOLUTION OF NUISANCE ALARMS THROUGH USER GUIDANCE. INVESTIGATION INCLUDED CUSTOMER SERVICE TROUBLESHOOTING AND USER EDUCATION REGARDING BG RUN MODE OPERATION, ALARM DISMISSAL, AND MANUAL BG ENTRY. INVESTIGATION OF THIS CASE REVEALED APPROPRIATE ILET FUNCTIONALITY IN BG RUN MODE WITH ALARMS OPERATING AS DESIGNED AFTER LOSS OF CONTINUOUS GLUCOSE MONITOR (CGM) DATA DUE TO ABSENT SENSOR AND NOT STARTING A NEW SENSOR. IT WAS CONCLUDED THAT THE EVENT WAS ATTRIBUTABLE TO USE ERROR RELATED TO CGM REPLACEMENT AND ABSENCE OF AN ACTIVE SENSOR, WITH THE ILET PERFORMING AS DESIGNED.