Description of Event or Problem · 0
IT WAS REPORTED THAT A USER OF THE ILET EXPERIENCED HYPERGLYCEMIA WITH SENSOR AND FINGERSTICK GLUCOSE VALUES IN THE 220¿290 MG/DL RANGE AFTER A MEAL, WITHOUT DEVICE ALARMS, AND INITIAL GUIDANCE WAS TO MONITOR BEFORE PROCEEDING TO A SUPPLY CHANGE; SUBSEQUENT EVALUATION FOUND NO TUBING LEAKS, DROPS WERE OBSERVED, AND A FULL SITE AND SUPPLY CHANGE WAS PERFORMED WITH INSULIN DELIVERY RESUMED, AFTER WHICH GLUCOSE TRENDED DOWN TO 113 MG/DL. SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE. OUTCOMES INCLUDED TRANSIENT HYPERGLYCEMIA THAT RESOLVED AFTER TROUBLESHOOTING AND SUPPLY REPLACEMENT, WITHOUT HOSPITALIZATION. INVESTIGATION INCLUDED GUIDED TROUBLESHOOTING, INSPECTION OF INFUSION TUBING FOR LEAKS OR DAMAGE, AND REPLACEMENT OF INFUSION SITE AND SUPPLIES. INVESTIGATION OF THIS CASE REVEALED NO CONFIRMED DEVICE MALFUNCTION AND THAT HYPERGLYCEMIA RESOLVED FOLLOWING A SITE CHANGE, CONSISTENT WITH AN UNCERTAIN CAUSE. 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.