Description of Event or Problem · 0
IT WAS REPORTED THAT THE ILET DISPLAYED RECURRENT INSULIN OCCLUSION ALERTS WHILE USING A CONTACT DETACH 6 MM STEEL INFUSION SET, RESULTING IN INTERRUPTED INSULIN DELIVERY AND PERSISTENT HYPERGLYCEMIA IN THE 230¿370 MG/DL RANGE, WHICH RESOLVED ONLY AFTER A FULL SUPPLY CHANGE AND REPEATED TROUBLESHOOTING INCLUDING TUBING INSPECTION, FILL TUBING, AND CANNULA FILL. CUSTOMER CARE PROVIDED SUPPORT WHICH INCLUDED GUIDED TROUBLESHOOTING TO CHECK FOR KINKS OR BLOCKAGES, AND RESUMPTION OF INSULIN DELIVERY AFTER SUPPLY CHANGES, ALONG WITH FOLLOW-UP CALLS TO ASSESS GLUCOSE TRENDS. INVESTIGATION OF THIS CASE REVEALED THAT THE OCCLUSION ALERTS PERSISTED DESPITE CLEAR TUBING AND VISIBLE DROPS DURING PRIMING, AND THAT REPLACING THE INFUSION SET AND SUPPLIES ALLOWED INSULIN DELIVERY TO RESUME WITHOUT FURTHER IMMEDIATE ALERTS, INDICATING AN INFUSION SET OR DISPOSABLE SUPPLY-RELATED OCCLUSION. NO CLINICAL SYMPTOMS ASSOCIATED WITH HIGH BLOOD GLUCOSE READINGS REPORTED. OUTCOMES INCLUDED TRANSIENT INTERRUPTION OF AUTOMATED INSULIN THERAPY AND THE NEED FOR MANUAL INSULIN INJECTIONS AND SUPPLY REPLACEMENT. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS AN INFUSION SET OCCLUSION RELATED TO DISPOSABLE COMPONENTS, RESOLVED BY SUPPLY CHANGE.