Description of Event or Problem · 0
IT WAS REPORTED THAT A USER EXPERIENCED HYPOGLYCEMIA TO 59 MG/DL, TREATED WITH FOOD AND LATER GLUCOSE GEL, FOLLOWED BY HYPERGLYCEMIA WITH ILET READINGS AROUND 203¿214 MG/DL AND A FINGERSTICK READING OF 225 MG/DL, AFTER WHICH GLUCOSE VALUES TRENDED DOWN TO 201 MG/DL; THE EVENT WAS CHARACTERIZED AS PATIENT OVERTREATMENT OF HYPOGLYCEMIA WITH NO DEVICE ALARMS AND THE ILET SYSTEM IN USE. CUSTOMER CARE PROVIDED SUPPORT THAT INCLUDED ASSESSMENT OF DEVICE READINGS VERSUS FINGERSTICK VALUES. INVESTIGATION OF THIS CASE REVEALED NO MALFUNCTION OR ALERT BEHAVIOR, WITH THE PATTERN CONSISTENT WITH SENSOR LAG RELATIVE TO CAPILLARY GLUCOSE AND REBOUND HYPERGLYCEMIA AFTER CARBOHYDRATE OVERTREATMENT. NO CLINICAL SYMPTOMS ASSOCIATED WITH HYPERGLYCEMIA REPORTED. OUTCOMES INCLUDED SELF-MANAGEMENT AT HOME WITHOUT MEDICAL INTERVENTION OR HOSPITALIZATION. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER-RELATED OVERTREATMENT OF HYPOGLYCEMIA LEADING TO TRANSIENT HYPERGLYCEMIA.