Description of Event or Problem · 0
IT WAS REPORTED THAT A USER EXPERIENCED ELEVATED GLUCOSE VALUES IN THE 180¿194 MG/DL RANGE AFTER A RECENT MEAL AND SUSPECTED INEFFECTIVE INSULIN DELIVERY FROM THE ILET SYSTEM. SYMPTOMS INCLUDED HYPERGLYCEMIA WITHOUT REPORTED ADVERSE CLINICAL EFFECTS. OUTCOMES INCLUDED RETURN TO TARGET RANGE FOLLOWING TROUBLESHOOTING AND SUPPLY REPLACEMENT, WITH NO ALERTS, ALARMS, OR NEED FOR MEDICAL INTERVENTION. INVESTIGATION INCLUDED GUIDED TROUBLESHOOTING TO PRIME TUBING AND CONFIRM INSULIN FLOW, REVIEW OF INFUSION SITE MANAGEMENT, AND A FULL SUPPLY CHANGE TO A STEEL INFUSION SET. INVESTIGATION OF THIS CASE REVEALED THAT INSULIN WAS FLOWING THROUGH THE TUBING AND THAT REPLACING THE INFUSION SET AND SUPPLIES RESOLVED THE ELEVATED READINGS, CONSISTENT WITH A POTENTIAL SITE OR SET-RELATED DELIVERY ISSUE OF UNCLEAR CAUSE. 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.