TANDEM TSLIM CONTROL IQ INSULIN PUMP
Received Feb 18, 2022 · Event occurred Feb 16, 2022
Report MW5107593 · MDR key 13579001
Device
Generic name
Interoperable Automated Glycemic Controller
Manufacturer
Tandem Diabetes Care, Inc.Model number
TSLIM CONTROL IQ INSULIN PUMPCatalog number
NA
Lot number
NA
Product problems
- Material Twisted/Bent
Patient
71 YR · Female
- Hyperglycemia
- Hyperglycemia
Narrative
Description of Event or Problem
THE TANDEM TSLIM CONTROL IQ INSULIN PUMP DOESN'T HAVE WARNING PATIENTS WHEN INSULIN ISN'T BEING DELIVERED. THIS HAPPENED TO ME TODAY RESULTING IN A BLOOD SUGAR OF OVER 400; ALTHOUGH THE PUMP SAID I STILL HAD ADEQUATE INSULIN ON BOARD. IT WAS VERY SCARY TO ME BECAUSE I DIDN'T KNOW IF IT WAS SAFE TO GIVE ADDITIONAL INSULIN. THE PROBLEM WAS A BENT CANULA INFUSION SET, UNABLE TO ME DETECTED. GENERALLY THE TANDEM TSLIM PUMP IS POORLY DESIGNED FOR USERS AND THIS IS ANOTHER EXAMPLE OF IT. CAN YOU MAKE THEM DO FOCUS GROUPS? GET BETTER ENGINEERS? INSTALL A SAFETY ALARM WHEN INSULIN ISN'T BEING DELIVERED? THANK YOU. FDA SAFETY REPORT ID# (B)(4).
Description of Event or Problem
THE TANDEM TSLIM CONTROL IQ INSULIN PUMP DOESN'T HAVE WARNING PATIENTS WHEN INSULIN ISN'T BEING DELIVERED. THIS HAPPENED TO ME TODAY RESULTING IN A BLOOD SUGAR OF OVER 400; ALTHOUGH THE PUMP SAID I STILL HAD ADEQUATE INSULIN ON BOARD. IT WAS VERY SCARY TO ME BECAUSE I DIDN'T KNOW IF IT WAS SAFE TO GIVE ADDITIONAL INSULIN. THE PROBLEM WAS A BENT CANULA INFUSION SET, UNABLE TO ME DETECTED. GENERALLY THE TANDEM TSLIM PUMP IS POORLY DESIGNED FOR USERS AND THIS IS ANOTHER EXAMPLE OF IT. CAN YOU MAKE THEM DO FOCUS GROUPS? GET BETTER ENGINEERS? INSTALL A SAFETY ALARM WHEN INSULIN ISN'T BEING DELIVERED? THANK YOU. FDA SAFETY REPORT ID# (B)(4).