T SLIM TANDEM INSULIN PUMP
Received Feb 21, 2025 · Event occurred Feb 14, 2025
Report MW5166615 · MDR key 21433506
Device
Generic name
Pump, Infusion, Insulin
Manufacturer
Tandem Diabetes Care, Inc.Patient
68 YR · Male
- Hyperglycemia
- Hyperglycemia
Narrative
Description of Event or Problem
I HAVE HAD TYPE 1 DIABETES FOR 61 YEARS AND AN INSULIN PUMP FOR 20. I AM AN EXPERIENCED DIABETIC AND AM KEENLY AWARE OF THE CHALLENGES OF MANAGING THE VARIOUS ISSUES LONG TERM DIABETES CAN PRESENT. LAST EVENING AT 5:00 PM-EST, I SWITCHED OUT THE TANDEM PUMP INFUSION SET, WHICH I HAVE DONE 100'S OF TIMES. MY BLOOD SUGAR AT THAT TIME WAS 150. MY BLOOD SUGAR WENT UP AND UP ALL EVENING AND NIGHT REGARDLESS OF HOW MUCH INSULIN I PUMPED. MY CGM (CONTINUOUS GLUCOSE MONITOR) AND GLUCOSE METER ONLY GO UP TO 600 SO I DON'T KNOW HOW HIGH IT ACTUALLY WENT. I ALSO INJECTED AN EXTRA DOSE OF 15 UNITS, AT 2:00AM WITHOUT ANY APPARENT IMPACT ON THE TERRIBLY HIGH BS (BLOOD SUGAR). WHEN I AWAKENED THIS MORNING AT 7:00AM MY BLOOD SUGAR WAS STILL OVER 600. I CHANGED THE TANDEM INFUSION SET AND THE VIAL OF LILLY U-100 INSULIN. I INJECTED AN ADDITIONAL BOLUS OF 15 UNITS. BLOOD SUGAR CAME DOWN AS EXPECTED. I DON'T KNOW IF THE FAILURE WAS TANDEMS INFUSION SET THE VIAL OF INSULIN SUDDENLY DIED.