Description of Event or Problem · 0
IT WAS REPORTED THAT THE USER EXPERIENCED ELEVATED BLOOD GLUCOSE WHILE USING THE ILET, WITH FINGERSTICK VALUES IN THE 190¿275 MG/DL RANGE AND CGM VALUES IN THE 234¿255 MG/DL RANGE, THE CGM INITIALLY OUTSIDE EXPECTED ACCURACY, FOLLOWED BY SUCCESSFUL CALIBRATION AND A SUBSEQUENT INFUSION SITE CHANGE AFTER PERSISTENT HYPERGLYCEMIA DESPITE NO RECENT FOOD INTAKE AND NO OBSERVED TUBING ISSUES. SYMPTOMS INCLUDED HYPERGLYCEMIA. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED TROUBLESHOOTING OF CGM CALIBRATION, TREND MONITORING, TUBING CHECKS FOR DROPS, AND AN INFUSION SITE CHANGE. INVESTIGATION OF THIS CASE REVEALED PERSISTENT ELEVATED GLUCOSE READINGS WITHOUT EVIDENCE OF LEAKAGE, KINKS, OR AIR IN THE TUBING, AND CALIBRATION OF THE CGM RESTORED EXPECTED SENSOR ALIGNMENT, SUGGESTING THE HYPERGLYCEMIA CAUSE WAS UNCLEAR. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.