Description of Event or Problem · 1
ON 06/06/08 THE PATIENT REPORTED ELEVATED BLOOD GLUCOSE READINGS FROM 176 MG/DL TO OVER 500 MG/DL BEGINNING IN 2008. SHE STATED HER INSULIN INFUSION DEVICE (COMPETITOR PRODUCT) GAVE AN OCCLUSION MESSAGE, SO SHE CHANGED HER INFUSION SET TUBING. THE FOLLOWING DAY SHE CALLED THE DEVICE MANUFACTURER WHEN HER READING ELEVATED TO OVER 500 MG/DL AND CHANGED HER CARTRIDGE, TUBING AND HEADSET. SHE SAID HER READING DECREASED TO 176 MG/DL AFTER THE CHANGE, BUT THEN INCREASED AGAIN. THE FOLLOWING DAY SHE CONTINUED TO HAVE ELEVATED READINGS AND AGAIN RECEIVED AN OCCLUSION MESSAGE. SHE TRIED A NEW TUBING FROM ANOTHER BOX AND HER READING DECREASED TO 269 MG/DL. SHE SAID SHE TRIED A NEW TUBING WITH THE SAME LOT NUMBER AND HAS NOT HAD AN OCCLUSION SINCE USING IT. DURING TROUBLESHOOTING, THE PATIENT STATED SHE CHANGES HER INFUSION HEADSET EVERY 3-4 DAYS AND HER TUBING ABOUT EVERY 20 DAYS. THE PATIENT WAS ADVISED TO CHANGE HER HEADSET EVERY 2 DAYS AND HER TUBING EVERY 6 DAYS. SHE SAID SHE DOES HAVE OCCLUSION MORE OFTEN THE LONGER HER TUBING IS IN USE. THE PATIENT WAS SENT A GUIDE TO INFUSION SITE MANAGEMENT ALONG WITH REPLACEMENT INFUSION SETS. ON FOLLOW UP, THE PATIENT HAS HAD SOME OTHER OCCLUSIONS WHICH SHE CLEARED BY DISCONNECTING FROM HER DEVICE AND PRIMING HER TUBING. SHE STATED HER BLOOD GLUCOSE READINGS HAVE IMPROVED. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.