CONTROL-IQ

Description of Event or Problem

WHILE SLEEPING THE TANDEM X2 INSULIN PUMP'S CONTROL-IQ SYSTEM CREATED A HYPOGLYCEMIC EVENT BY DELIVERING TWO CORRECTION BOLUSES DURING THE NIGHT (0.86@ 1:52A, 0.85U @3:38A), AT APPROX. 4:40A THE SYSTEM PREDICTED AN IMMINENT HYPOGLYCEMIC CONDITION SO BASAL DELIVERIES WERE STOPPED. BUT THIS LASTED FOR ONLY ROUGHLY 20 MINUTES BEFORE BASAL DELIVERY RESUMED AROUND 3:50A. ROUGHLY 30 MINUTES LATER THE SYSTEM DETECTED ANOTHER POTENTIAL HYPOGLYCEMIC EVENT AND STOPPED BASAL FOR 90 MINUTES. THESE EVENTS RESULTED IN A DANGEROUSLY LOW BLOOD GLUCOSE LEVEL SOMEWHERE AROUND OR BELOW 50MG/DL. IT WAS ONLY AFTER I AWOKE IN A DANGEROUSLY LOW CONDITION AND STAIRS TO CORRECT AT AROUND 7:00A. THERE ARE THREE RELATED ISSUES REGARDING THIS EVENT: 1) REVIEWING THIS EVENT WITH MY DOCTOR WE FOUND NO GOOD REASON WHY AFTER PAUSING BASAL THE CONTROL-IQ ENABLED BASAL DELIVERY WHILE GLUCOSE LEVELS WERE LOW. TANDEM WAS CONTACTED TO REPORT THE INCIDENT, AND THEY WERE ASKED TO INVESTIGATE THE EVENT AND EXPLAIN WHAT HAPPENED. THE RESULT OF THEIR FINDINGS WERE THE SYSTEM WAS "WORKING AS EXPECTED", THERE WAS NO DATA TO SUPPORT THIS POSITION. TANDEM FELT IT DIDN'T NEED ANY FURTHER SUPPORT TO JUSTIFY WHY THIS WAS "CORRECT". 2) IT MAY HAVE BEEN NOTICED IN THE DATA PRESENTED, OTHER THAN CORRECTION BOLUS VALUES, THERE ARE NO DEFINITIVE VALUES. THE REASON FOR THIS IS THAT TANDEM DOES NOT PROVIDE A PATIENT'S PERSONAL MEDICAL DATA TO ITS PATIENT. 3) TANDEM DOES NOT MAKE THE ACTUAL PUMP DATA AVAILABLE TO ITS PATIENTS. BLOCKING ACCESS TO ONE'S PERSONAL MEDICAL DATA IS NOT ONLY UNACCEPTABLE BUT ALSO PREVENTS PATIENTS FROM EFFECTIVELY MANAGING THEIR DIABETES. TANDEM SUPPORT SUPERVISOR, MOLLY, INSTRUCTED ME THAT IF I WANT THE DATA FOR THIS EVENT I NEED TO CONTACT TANDEM'S GENERAL COUNCIL AT THE FOLLOWING ADDRESS: TANDEM DIABETES CARE; ATTN: GENERAL COUNCIL; (B)(4). THIS IS UNACCEPTABLE ON SEVERAL LEVELS INCLUDING: THIS PRESENTS AN INCONVENIENCE TO THE PATIENT; A PATIENT'S PERSONAL MEDICAL DATA IS THEIRS AND THEY HAVE RIGHTS TO ACCESS THEIR PERSONAL MEDICAL DATA; IF LAWYERS ARE REQUIRED FOR A PATIENT TO ACCESS THEIR PERSONAL MEDICAL DATA THERE'S A SERIOUS PROBLEM WHICH NEEDS TO BE ADDRESSED. DEXCOM, WHICH MANUFACTURES THE PAIRED GLUCOSE MONITOR, MAKES ALL COLLECTED DATA AVAILABLE TO THE PATIENT AND PROVIDERS VIA THEIR WEBSITE. MEDTRONIC, WHICH MANUFACTURES AN INSULIN PUMP WITH SIMILAR FEATURES, PROVIDES ALL PUMP AND GLUCOSE READING DATA FOR ITS PATIENTS AND PROVIDERS VIA THEIR WEBSITE. TANDEM DOES NOT MAKE PATIENT DATA AVAILABLE TO PATIENTS AND PROVIDERS, INSTEAD TANDEM PROVIDES PRETTY PICTURES LACKING SPECIFIC VALUES AND TIMES. AS AN EXAMPLE, IN THE ATTACHED "REPORT" FROM TANDEM OF THE EVENTS OF 4/22/2024 IT'S NOT POSSIBLE TO DETERMINE EXACTLY HOW LOW THE BLOOD SUGARS REACHED. THERE'S A BIG HIGHLIGHTED 57, BUT THAT'S NOT THE LOWEST VALUE. THE LOWEST VALUE IS A MYSTERY THAT ONE CAN GUESS IS AT OR BELOW 50 BASED ON THE AXIS VALUE FOUND ON THE RIGHT AXIS. BUT WE'RE TALKING DANGEROUSLY LOW, AND WE DON'T HAVE ACCESS TO THAT EXACT VALUE. I'VE UPLOADED THE ONLY VIEW I HAVE OF THIS EVENT, THERE IS NO ADDITIONAL, MORE SPECIFIC, DETAILS I CAN PROVIDE BECAUSE I'M BLOCKED FROM MY PERSONAL MEDICAL PUMP DATA. I CANNOT PROVIDE EXACT VALUES FOR LOW OR HIGH BECAUSE THOSE VALUES ARE NOT AVAILABLE TO ME. (SEE POINT 3 IN THE REPORT). REFERENCE REPORT: MW5154593.