Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT¿S MOTHER CONTACTED ANIMAS TO REPORT THAT THE PATIENT HAD BEEN OBTAINING HIGH BLOOD GLUCOSE (BG) READINGS ALL WEEKEND. THE REPORTER STATED THE PATIENT¿S BG ON (B)(6) 2013 RANGED FROM ¿192-593 MG/DL¿ AND ON (B)(6) 2013, RANGED FROM ¿44-465 MG/DL¿. THE REPORTER STATED THAT THE PATIENT TESTED POSITIVE FOR SMALL KETONES WHEN BG OF ¿593 MG/DL¿ WAS OBTAINED. THE PATIENT¿S MOTHER STATED SHE HAD THE PATIENT EXERCISE IN RESPONSE TO ELEVATED RESULT(S). AT THE TIME OF THE CALL, THE REPORTER INFORMED THE ANIMAS REPRESENTATIVE THAT THE PATIENT¿S LAST BG READING WAS 122 MG/DL. AT THE TIME OF THE CALL THE PUMP¿S BOLUS AND PRIME HISTORY WERE REVIEWED AND THE ANIMAS REPRESENTATIVE DISCOVERED THAT THE PUMP WAS NOT PRIMED AFTER SITE WAS CHANGED ON THE MORNING OF (B)(6) 2013. IT WAS NOTED THAT SEVERAL NORMAL BOLUSES (AMOUNTS NOT SPECIFIED) WERE ADMINISTERED TO THE PATIENT WITHIN A 15 MINUTE PERIOD RIGHT AFTER THE SITE WAS CHANGED. THE REPORTER DID NOT REMEMBER REASON THE BOLUSES WERE ADMINISTERED. IN ADDITION, THE REPORTER CLAIMED SHE DID NOT RECALL BEING TOLD TO PRIME THE TUBING AFTER SITE CHANGES. ANIMAS CUSTOMER SUPPORT ATTEMPTED TO REACH THE REPORTER AFTER INITIAL CALL TO ANIMAS TO REVIEW PUMP SETTINGS AND HISTORY; HOWEVER, WERE UNSUCCESSFUL IN THEIR ATTEMPTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY. INSULIN PUMP USE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.