Description of Event or Problem · 1
IN 2008, THE PATIENT CALLED FOR ASSISTANCE IN PRIMING HIS INSULIN INFUSION SET WHICH HE SUCCESSFULLY DID. HE THEN REQUESTED HELP WITH SETTING THE TIME AND DATE ON HIS INSULIN INFUSION DEVICE, BUT STATED HE WILL CALL BACK WHEN HIS WIFE IS AVAILABLE, AS HE IS BLIND AND WILL NEED HER ASSISTANCE. THE PATIENT'S WIFE CALLED BACK FOR ASSISTANCE IN SETTING THE TIME BUT WHEN SHE TRIED TO CHANGE THE TIME AND DATE, SHE STATED THE SCREEN LOOKED LIKE A "CHILD HAS SCRIBBLED ON IT". SHE SAID THE SCREEN HAS BLACK SPOTS ON IT AND ALL THAT IS LEGIBLE IS A "1" AND THEN A "11-04" IN THE RIGHT-HAND CORNER. THE PATIENT'S WIFE STATED THAT LAST WEEK THE PATIENT, WHILE CHANGING HIS INSULIN CARTRIDGE, PULLED THE NEARLY EMPTY ONE "OUT TOO SOON" AND INSULIN SPILLED INTO THE CARTRIDGE CHAMBER. SHE DRIED IT OUT WITH A COTTON SWAB AND HAS HAD NO ISSUES UNTIL THIS MORNING. SHE SAID THIS MORNING, THE DEVICE WAS IN THE RUN MODE AND THE SCREEN HAD A "7 UNIT" ON IT BUT THEY HAD NOT PROGRAMMED A BOLUS. SHE SAID THEY PUT THE DEVICE IN THE STOP MODE, BUT THE DEVICE STILL BEGAN TO DELIVER THE INSULIN, SO THE PATIENT DISCONNECTED, SO HE DID NOT RECEIVE THE BOLUS. SHE SAID THEY HAVE NOW REMOVED THE BATTERY BUT THE SCREEN STILL HAS THE "FUNNY DRAWING STUFF ON IT". THE PATIENT WILL SWITCH TO INSULIN INJECTION THERAPY. NO BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.