Description of Event or Problem · 1
THE PATIENT'S MOTHER REPORTED, THE PATIENT RECEIVED AN 04 (OCCLUSION) MESSAGE ON HER INSULIN INFUSION DEVICE AND WOKE UP WITH AN ELEVATED BLOOD GLUCOSE READING OF OVER 600 MG/DL. SHE STATED, THE PATIENT'S RECOMMENDED RANGE IS 80-240 MG/DL. SHE SAID, THE PATIENT CHANGED THE INFUSION SET AND THEN, WHILE WEARING THE DEVICE, RECEIVED ANOTHER OCCLUSION MESSAGE WHICH THE PATIENT CLEARED. SHE STATED, THE PATIENT HAS NOT RECEIVED ANY MORE OCCLUSION MESSAGES. THE PATIENT'S MOTHER WAS INSTRUCTED TO CHECK THE BATTERY AND THE EXPIRATION DATE WAS 03/2008. COMPLIMENTARY BOXES OF INFUSION SETS, A PISTON ROD AND BATTERY WERE SENT TO THE PATIENT. ON FOLLOW UP, THE PATIENT'S MOTHER STATED THAT WHEN THE INFUSION SET WAS REMOVED, THE CANNULA WAS BENT. SHE STATED, THE INFUSION SET WAS DISCARDED. ON FURTHER FOLLOW UP, THE PATIENT'S MOTHER REPORTED ANOTHER OCCLUSION MESSAGE WHICH WAS CLEARED WHEN THE PATIENT CHANGED INFUSION SETS. SHE STATED, THE PATIENT AGAIN HAD AN ELEVATED BLOOD GLUCOSE READING THAT MEASURED "HI" ON HER METER. SHE SAID, SHE CORRECTED THE PATIENT'S READING BY GIVING HER AN INJECTION OF INSULIN. SHE STATED, THE PATIENT IS USING ALL OF THE SUPPLIES SENT TO HER. SHE SAID SHE CAN SUCCESSFULLY PERFORM A PRIME WITH AND WITHOUT THE PISTON ROD BUT, WHEN SHE PUTS THE CARTRIDGE IN WITH THE ADAPTER, SHE RECEIVES AN OCCLUSION MESSAGE. ON FOLLOW UP, THE PATIENT'S MOTHER STATED THE PATIENT IS USING THE REPLACEMENT INFUSION DEVICE AND HER READINGS ARE WITHIN HER NORMAL RANGE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.