Description of Event or Problem · 1
ON 06/06/08, THE PATIENT REPORTED ELEVATED BLOOD GLUCOSE READINGS BEGINNING THE PREVIOUS MONTH. HE STATED HE CHANGED HIS INSULIN INFUSION SET AND CARTRIDGE ON THAT DAY AND PRIMED THE INFUSION SET TUBING. HE SAID ON TWO DAYS LATER, HE CALLED THE AMBULANCE TO TAKE HIM TO THE HOSPITAL AS HIS READINGS WERE STILL ELEVATED AND HE WAS VOMITING. HE STATED HIS READING UPON ADMISSION TO THE HOSPITAL WAS 1080 MG/DL, AND HE WAS TAKEN OFF HIS INSULIN INFUSION DEVICE AND GIVEN AN INSULIN DRIP. THE PATIENT SAID HE IS CURRENTLY ON INJECTION THERAPY AS HIS DOCTOR WANTS HIM TO REMAIN OFF HIS INFUSION DEVICE UNTIL HIS READINGS ARE UNDER BETTER CONTROL. HE SAID HIS CURRENT READINGS ARE BETWEEN 150-250 MG/DL WITH HIS RECOMMENDED RANGE BEING 120-150 MG/DL. DURING TROUBLESHOOTING, THE PATIENT WAS UNABLE TO VERIFY THE SERIAL NUMBER ON HIS INFUSION DEVICE DUE TO VISUAL IMPAIRMENT. HE STATED HE WAS NOT SURE HOW LONG THE BATTERY HAD BEEN IN THE DEVICE. THE PATIENT CONFIRMED THE TIME AND DATE ON HIS INFUSION DEVICE WAS CORRECT. THE PATIENT WAS INSTRUCTED TO USE A NEW CARTRIDGE, ADAPTER, TUBING, AND INFUSION SET AND TO PRIME THE TUBING WHICH HE DID WITHOUT ERROR. WHEN THE ALARM HISTORY WAS CHECKED, IT WAS DISCOVERED HIS INFUSION DEVICE DISPLAYED AN E3 (AUTOMATIC OFF) ON THE DAY HE WENT INTO THE HOSPITAL. HE STATED HE HAS THE DEVICE PROGRAMMED TO AUTOMATICALLY SHUT OFF IF NO BUTTON HAS BEEN PRESSED FOR 10 HOURS. THE PATIENT DECLINED TO DEACTIVATE THIS FEATURE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.