Description of Event or Problem · 1
ON (B)(6) 2010, CLINICAL SPECIALIST REPORTED, SHE RECEIVED A CALL FROM THE PT WITH AN ISSUE REGARDING HIS CURRENT SUPPLY OF INFUSION SETS FALLING APART. CLINICAL SPECIALIST STATED, SHE ADVISED THE PT TO SAVE THEM AND TO CALL PUMP SUPPORT. ON F/U CALL TO PT ON (B)(6) 2010, PT STATED HIS CURRENT BOX AND THE LAST BOX OF INFUSION SETS THAT HE IS USING HAVE BEEN FALLING APART AT THE SEAM WHERE THE INFUSION HEADSET CONNECTS TO THE INFUSION TUBING. PT STATED ON (B)(6) 2010, HE HAD ONE THAT CAME APART AT THE SEAM NEXT TO THE LUER LOCK, NOT THE LOCK ITSELF, AND WAS LEAKING INSULIN WHILE HE WAS AT WORK. PT REPORTED WHEN THE INFUSION SETS CAME APART AT THE HEADSET, THE TUBING WOULD FALL OFF AND HANG DOWN AND ALTHOUGH, THE ADHESIVE STAYED ON, IT WOULD PULL THE CANNULA OUT OF HIS BODY. PT STATED, HE NOTICED THESE RIGHT AWAY BEFORE IT AFFECTED HIS BLOOD GLUCOSE. PT REPORTED ON (B)(6) 2010, HE WAS TRYING TO DELIVER A BOLUS FOR CORRECTION WHILE AT WORK BECAUSE, HIS BLOOD GLUCOSE HAD BEEN RISING ALL MORNING AND WAS AT 270 MG/DL; HE SAW INSULIN DRIPPING ONTO SOME PAPERS ON HIS DESK AND HIS SHIRT WAS WET. PT STATED, HE LOOKED CLOSER AND SAW THE INSULIN WAS DRIPPING OUT AT THE SEAM NEXT TO THE LUER LOCK. PT REPORTED, HE HAD TO GO HOME TO CHANGE THE INFUSION SET AND WENT AHEAD AND GAVE A 10.0 UNIT CORRECTION OF INSULIN WITH A SYRINGE AND THEN HIS GLUCOSE CAME DOWN TO HIS NORMAL LEVEL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 110-140 MG/DL. PT REPORTED, HE CHECKED HIS BLOOD GLUCOSE PRIOR TO GOING TO WORK WITH A READING OF 131 MG/DL, BOLUSED 2.0 UNITS OF INSULIN AND THEN WHILE AT WORK HE HAD BEEN SNACKING. PT STATED EACH TIME HE TESTED FOR SNACKS; HIS GLUCOSE WAS INCREASING RATHER THAN GOING DOWN. PT REPORTED, HE NOTICED THE INSULIN LEAKING WHEN HE WAS GETTING READY TO EAT HIS LUNCH. PT STATED, HE WAS HAVING SYMPTOMS OF ELEVATED BLOOD GLUCOSE; HIS TONGUE FELT BIG AND THICK AND PASTY, AND HIS LEGS FELT SLUGGISH. PT REPORTED, THE INCIDENT ON (B)(6) 2010 WAS THE ONLY ONE THAT LED TO AN ELEVATED BLOOD GLUCOSE BECAUSE, HE WAS NOT RECEIVING THE INSULIN, ALL THE OTHER TIMES HE NOTICED THE TUBING HAD BROKEN AND WAS ABLE TO CHANGE THE INFUSION SET BEFORE IT AFFECTED HIS BLOOD GLUCOSE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.