Description of Event or Problem · 0
IT WAS REPORTED THAT THE USER EXPERIENCED HYPERGLYCEMIA WHILE USING THE ILET WITH A CD STEEL 6 MM, 23-INCH INFUSION SET, LOT 6013997, AFTER A RECENT SUPPLY CHANGE; THE USER SUSPECTED THE INFUSION SITE WAS IN SCAR TISSUE, OBSERVED INSULIN LEAKING FROM THE PRIOR SITE UPON REMOVAL, AND PERFORMED A GUIDED SITE CHANGE INCLUDING FILL TUBING AND FILL CANNULA, AFTER WHICH INSULIN THERAPY RESUMED. SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE OF 383 MG/DL WITHOUT REPORTED PHYSICAL SYMPTOMS. OUTCOMES INCLUDED CONTINUATION OF INSULIN THERAPY WITH PLANNED FOLLOW-UP ON BLOOD GLUCOSE. INVESTIGATION INCLUDED CUSTOMER SUPPORT TROUBLESHOOTING AND EDUCATION ON SITE CHANGE AND PRIMING STEPS. INVESTIGATION OF THIS CASE REVEALED A PROBABLE INFUSION SITE ABSORPTION ISSUE WITH SUSPECTED USE OF SCAR TISSUE AND LEAKAGE UPON SITE REMOVAL, CONSISTENT WITH DELIVERY WITHOUT ABSORPTION AT THE PRIOR SITE. 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.