Description of Event or Problem · 0
IT WAS REPORTED THAT AN ILET USER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE OF 231 MG/DL AFTER A SMALL MEAL, FOLLOWING A BENT CANNULA EARLIER IN THE DAY AND INFUSION SET PLACEMENT UNDER THE RIB CAGE; THE USER RECEIVED TROUBLESHOOTING AND EDUCATION, INCLUDING ADVICE TO CHANGE INFUSION SITES, AND CHOSE TO WAIT FOR GLUCOSE TO DECLINE. SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE. OUTCOMES INCLUDED NO HOSPITALIZATION AND NO DEVICE ALERTS OR ALARMS. INVESTIGATION INCLUDED A CUSTOMER INTERVIEW AND TROUBLESHOOTING. INVESTIGATION OF THIS CASE REVEALED USER-REPORTED INFUSION SET INSERTION DIFFICULTY CONSISTENT WITH A BENT CANNULA, WITH POSSIBLE SUBOPTIMAL INFUSION SITE SELECTION; DEVICE FUNCTION APPEARED NORMAL. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNDETERMINED. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.