CONTROL IQ
Received Nov 7, 2023 · Event occurred Oct 13, 2023
Report MW5147888 · MDR key 18092276
Device
Generic name
Interoperable Automated Glycemic Controller
Manufacturer
Tandem Diabetes Care, Inc.Patient
51 YR · Prefer Not To Disclose
- Pain
- Dysphasia
- Shaking/Tremors
- Sleep Dysfunction
- Pain
- Dysphasia
- Shaking/Tremors
- Sleep Dysfunction
Narrative
Description of Event or Problem
THE AUTOMATIC CORRECTION BOLUS WENT OFF EVEN THOUGH IT WAS NOT SUPPOSED TO. MY SLEEP SCHEDULE IS FROM 9PM TO 8 AM MONDAY TO SUNDAY. WHILE IN CONTROL IQ THIS AUTOMATIC FEATURE IS SUPPOSED TO BE OFF. QUITE HONESTLY I WAS IN THE 50 IT TOOK MY HUSBAND 45 MINUTES TO WAKE ME UP DUE TO THE GABAPENTIN, LORAZEPAM, TOPIRAMATE, MONTELUKAST. AND IF I HAD A CYCLOBENZAPRINE THAT NIGHT I WAS A HARD WAKE UP BECAUSE MY HIPS AND SHOULDERS BOTH HAVE BONE SPURS AND THE SCIATICA IS ALSO A NERVE PAIN I DON'T WISH ON ANYONE. BUT BEING 50 AND NEEDING MY HUSBAND'S HELP TO WALK BECAUSE I WAS SHAKING SO MUCH FROM THE LOW AND THE FACT I WAS HAVING TROUBLE COMMUNICATING IS A PROBLEM FOR ME. IT'S A PROBLEM FOR EVERYONE USING THE TANDEM AND CONTROL IQ. BECAUSE TO TURN OFF THE AUTOMATIC CORRECTION BOLUS I WOULD NEED TO TURN OFF THE CONTROL IQ. MY PHYSICIAN DOES NOT WANT THAT, DR (B)(6). 1) TO NOT GIVE THE USER A CHOICE IN WHETHER THEY WANT THE AUTOCORRECT BOLUS TO DELIVER IS NOT GOOD MEDICAL ADVICE. 2) TO NOT GIVE A CHOICE BUT TO TURN OFF CONTROL IQ THE WHOLE REASON FOR PURCHASING THE EXPENSIVE PIECE OF EQUIPMENT IS RIDICULOUS AND STUPID. I MIGHT AS WELL GO BACK TO SHOTS. 3) TO NOT LISTEN TO A PUMPER WHO WAS HERE FROM THE START OF INSULIN PUMP IN THE US IS IGNORANCE AND NOT TAKING THE KNOWLEDGE OF AN RF ELECTRICAL ENGINEER. REFERENCE REPORT: MW5147887.