Description of Event or Problem · 1
IN EARLY 2009, MY SON STARTING HAVING PROBLEMS WITH HIS DIABETES. HE WAS ON THE USING OF PARADIGM 522 WITH THE QUICK SET. HIS BLOOD SUGAR READINGS WERE AS HIGH AS 500 AND AS LOW AS 20. HE STARTED SEEING A NEW DOCTOR WHO WAS CLOSER TO OUR HOUSE. THREE MONTHS LATER, HE HAD A DIABETES SEIZURE FROM A LOW BLOOD SUGAR, THE GLUCOSE SHOT WAS GIVEN AND HE AWOKE. THE EMTS WERE CALLED BUT HE WAS NOT TAKEN TO THE HOSPITAL THIS TIME. APPROX THREE MONTHS LATER, MY SON HAD ANOTHER DIABETIC SEIZURE FROM A LOW BLOOD SUGAR, THE GLUCOSE SHOT WAS GIVEN AND THE EMT'S WERE CALLED. HE DID NOT RESPOND AND KEPT SEIZURING. FOR ABOUT SIX HOURS, THE HOSPITAL TRIED TO GET THE SEIZURE TO STOP BUT WAS UNSUCCESSFUL. HIS BLOOD SUGAR KEPT DROPPING. HE WAS THEN TRANSPORTED TO HOSP WHERE HE WAS UNCONSCIOUS FOR THREE DAYS. HE WAS THEN TRANSPORTED TO ANOTHER HOSPITAL WHERE THEY CONTINUED TO MONITOR HIM AND THEN HE WAS RELEASED AFTER TWO DAYS. HE HAD SOME SHORT TERM MEMORY LOSS THAT WOULD COME BACK IN TIME, AND ALSO SOME PERSONALITY CHANGES THAT ALSO WOULD COME BACK. TWO WEEKS AFTER THIS, MY SON HAD ANOTHER SEIZURE -STILL USING THE PUMP-. THE GLUCOSE SHOT WAS GIVEN AND THE EMTS WERE CALLED. MY SON DID RESPOND TO THE SHOT AND TOLD ME THAT HE HAD GIVEN HIMSELF TOO MUCH INSULIN WITH HIS PUMP BECAUSE HE WAS FRUSTRATED WITH ALL THE HIGH AND LOW NUMBERS. I TOOK HIM TO THE HOSPITAL WERE HE BEGAN TO SEIZURE AGAIN. GLUCOSE WAS GIVEN AND HE WAS TRANSPORTED TO THE HOSPITAL. AFTER A WEEK, HE WAS TAKEN TO ANOTHER HOSP FOR EVALUATION. MY SON INSISTED THAT HE ONLY GAVE HIMSELF THE INSULIN ON PURPOSE ONCE. WE DISCONTINUED THE USE OF THE PUMP AND WENT TO SHOTS HUMALOG AND LANTUS. APPROX TWO MONTHS LATER, I RECEIVED A PHONE CALL INFORMING ME THAT ALL QUICK SETS FROM THE PUMP WITH THE LOT NUMBER STARTING WITH AN 8 WERE ON RECALL BECAUSE OF A MALFUNCTION CAUSING TOO MUCH INSULIN OR NOT ENOUGH TO GO INTO THE BODY. THE RECALL WAS GOING BACK AS FAR AS EARLY 2009. I CHECKED MY BOXES LEFT FROM MY SON'S PUMP AND FOUND THEM ALL TO START WITH THE LOT NUMBER 8. SEEMS TO ME THAT THIS COULD HAVE BEEN THE CAUSE OF ALL OF THE PROBLEMS WE HAVE HAD WITH MY SON'S NUMBERS SINCE THE SAME MONTH IN EARLY 2009. FREQUENCY: EVERY TWO DAYS. ROUTE: SQ. DATES OF USE: 2004 - 2009. DIAGNOSIS: JUVENILE DIABETES. EVENT ABATED AFTER USE STOPPED: YES. PARADIGM QUICK-SET USED WITH THE PARADIGM MINIMED 522 PUMP FOR DIABETES. IS USED 24 HOURS A DAY. THE QUICK SET IS CHANGED EVERY TWO DAYS.