Description of Event or Problem · 0
IT WAS REPORTED THAT A USER EXPERIENCED HYPERGLYCEMIA WHILE USING AN ILET SYSTEM AFTER A SUPPLY CHANGE, WITH A REPORTED BLOOD GLUCOSE OF 338 MG/DL; THE AGENT INSTRUCTED ANOTHER SUPPLY CHANGE, RESUMED INSULIN DELIVERY, AND ARRANGED REPLACEMENT SUPPLIES, NOTING PRIOR PREMATURE CHANGES OF INFUSION COMPONENTS (CARTRIDGE LOT 34974, CONNECTOR LOT 35096, TEFLON INSET LOT 6010685). SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE TO A PEAK OF 400 MG/DL. OUTCOMES INCLUDED USER TROUBLESHOOTING AND REPLACEMENT SUPPLIES. INVESTIGATION INCLUDED CUSTOMER INTERVIEW AND GUIDED TROUBLESHOOTING. INVESTIGATION OF THIS CASE REVEALED THAT THE CAUSE OF THE HYPERGLYCEMIA WAS UNCLEAR, WITH NO ALERTS OR ALARMS REPORTED AND NO DEVICE MALFUNCTION CONFIRMED. 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.