Description of Event or Problem · 1
IN 2008, THE PT REPORTED THAT SINCE THE BEGINNING OF THE PREVIOUS MONTH, SHE HAS EXPERIENCED AIR BUBBLES THAT APPEAR TO BE FORMING NEAR THE LUER CONNECTION OF THE INFUSION TUBING AND THE TOP OF THE INSULIN CARTRIDGE. SHE STATED THAT THE AIR BUBBLES APPEAR 24 HOURS AFTER USE AND SHE CONTINUES TO CHANGE THE INFUSION TUBING IN AN ATTEMPT TO RESOLVE THE ISSUE. SHE STATED THAT TODAY SHE CONTINUES TO SEE AIR BUBBLES AND HER BLOOD GLUCOSE WAS ELECTED TO 200-350 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. SHE INSERTED A NEW INSULIN CARTRIDGE INTO THE INFUSION DEVICE, THE INSULIN WAS ROOM TEMPERATURE, AND PRIMING WAS PERFORMED WITH THE ADAPTER UPRIGHT. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND TO RETRACT THE PISTON ROD. SHE THEN PRIMED THE PISTON ROD FORWARD TO MATCH THE VOLUME OF INSULIN IN THE CARTRIDGE. USING NEW INFUSION TUBING, THE PT WAS ABLE TO PRIME ALL OF THE AIR BUBBLES FROM THE INSULIN CARTRIDGE. WITHIN MINUTES THE PT STATED THAT AIR BUBBLES WERE FORMING NEAR THE PLUNGER OF THE INSULIN CARTRIDGE. SHE STATED THAT THE LUER OF THE INFUSION TUBING SEEMED TO BE BIGGER THAN NORMAL. REPLACEMENT INFUSION SETS WERE SENT TO THE PT. UPON FOLLOW UP ON THREE DAYS AFTER THE ORIGINAL DATE, THE PT STATED THAT THE REPLACEMENT INFUSION SETS RESOLVED THE ISSUE AND HER BLOOD GLUCOSE WAS "BELOW 100 MG/D." THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.