Description of Event or Problem · 0
IT WAS REPORTED THAT A NEW ILET USER EXPERIENCED AN INITIAL HIGH GLUCOSE AROUND 280 MG/DL, THEN A SUBSEQUENT LOW AROUND THE 60 MG/DL, PROMPTING THE CAREGIVER TO PAUSE AND DISCONNECT THE ILET AND THE PATIENT TO INGEST A PEANUT BUTTER SANDWICH; FOLLOWING THIS, A FINGERSTICK MEASURED 443 MG/DL. CUSTOMER CARE PROVIDED SUPPORT THAT INCLUDED FOLLOW-UP AND DEVICE-USE TROUBLESHOOTING WITH EDUCATION REGARDING TREATMENT OF HYPOGLYCEMIA AND HYPERGLYCEMIA. INVESTIGATION OF THIS CASE REVEALED AN UNCLEAR CAUSE FOR THE HYPOGLYCEMIA AND SUBSEQUENT REBOUND HYPERGLYCEMIA AFTER PROBABLE OVERTREATMENT, WITH NO DEVICE MALFUNCTION REPORTED. NO CLINICAL SYMPTOMS ASSOCIATED WITH THE HYPERGLYCEMIA AND HYPOGLYCEMIA REPORTED. OUTCOMES INCLUDED NO HOSPITALIZATION. 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.