Description of Event or Problem · 1
ON (B)(6) 2010, PT REPORTED SHE RECEIVED ERRATIC BLOOD GLUCOSE READINGS RANGING FROM 'HI' TO AS LOW AS 40 MG/DL OVER THE PAST 2 PLUS MONTHS. PT STATED ON (B)(6) 2010, SHE WENT TO THE HOSPITAL FOR AN ELEVATED BLOOD GLUCOSE AND IT WAS DETERMINED THAT THE INSULIN WAS 'SPOILED'. PT REPORTED THE INSULIN APPEARED TO BE 'GELLED' AND SHE WAS TREATED FOR ELEVATED BLOOD GLUCOSE AND RELEASED. PT STATED THE INFUSION DEVICE CONCERNS HAVE PERSISTED SINCE THAT TIME. PT'S NORMAL BLOOD GLUCOSE RANGE IS AROUND 110-170 MG/DL. PT REPORTED EVERY TIME SHE ATTEMPTS A BOLUS OF APPROXIMATELY 10.0 UNITS OF INSULIN, THE INFUSION DEVICE GIVES AN E4 (OCCLUSION) ERROR. PT STATED SINCE SHE IS UNABLE TO PERFORM A BOLUS, SHE THEN GIVES HERSELF ADDITIONAL INSULIN SHOTS WHICH OFTEN RESULTS IN HER BLOOD GLUCOSE TEMPORARILY GOING TOO LOW. PT REPORTED WHEN SHE RECEIVES AN E4, SHE WILL CHANGE OUT THE INFUSION SET AND INSULIN CARTRIDGE, PRIME THE INFUSION DEVICE AND PLACE THE DEVICE INTO RUN MODE. PT STATED THE OCCLUSION TYPICALLY OCCURS 6-8 HOURS LATER WHEN SHE ATTEMPTS A BOLUS. PT REPORTED THE INFUSION ADAPTER WAS CHANGED APPROXIMATELY 6 MONTHS AGO. ADVISED TO CHANGE ADAPTER WITH EVERY 10TH INSULIN CARTRIDGE CHANGE. PT STATED THE INSULIN CARTRIDGE IS ONLY IN USE FOR 6-8 HOURS PRIOR TO THE OCCLUSION. PT REPORTED THE INSULIN IS USUALLY NOT WARMED TO ROOM TEMPERATURE PRIOR TO INSTALL. ADVISED TO ALWAYS ALLOW INSULIN TO WARM TO ROOM TEMPERATURE PRIOR TO INSTALLING. PT STATED CONDENSATION OFTEN APPEARS INSIDE OF THE CARTRIDGE COMPARTMENT AND SHE ATTEMPTED TO DRY IT WITH A BLOW DRYER. ADVISED DRYING WITH A COTTON SWAB. PT REPORTED SHE HAS BEEN ON HER BACKUP INFUSION DEVICE FOR 2 DAYS WITHOUT ERROR, ALL BOLUSES WERE SUCCESSFUL AND HER BLOOD GLUCOSE IS BACK TO A CONSISTENT LEVEL WITH READINGS AROUND 112 MG/DL. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.