Tandem Diabetes Care (Nasdaq:TNDM) issued an urgent field safety notice in Europe for its t:slim X2 insulin pump with Basal-IQ technology.
The notice, dated February 2022, alerts users of Tandem’s insulin pump with a software version of 220.127.116.11 that there may be a potential safety risk when using the pump within its normal specifications. Tandem’s t:slim X2 with Control-IQ technology is not affected.
According to the notice, Tandem’s insulin pumps include a “Personal Profile” feature that allows users to personalize the settings that define the delivery of basal and bolus insulin within specific time segments in a 24-hour period. After a user inputs a basal rate into the screen, a “Confirm Settings?” screen is displayed and must be acknowledged, but a user could inadvertently program and confirm a basal rate with an incorrectly placed decimal point.
Inputting incorrect values can lead to under-delivery or over-delivery of insulin, which could result in hyperglycemia or hypoglycemia. Users have been informed by Tandem that they can continue using the pump with extra precautions:
- Take extra care when creating or editing your personal profile.
- Confirm the basal rate change was correctly entered in the “Confirm Settings?” page.
- Double-check all values entered before advancing past “Confirm Settings?”
- Regularly check blood sugar to ensure that levels are not unexpectedly high or low.
Tandem will be releasing a t:slim X2 with Basal-IQ technology software update that rectifies the issues noted above, while the company has already implemented an additional feature called “Basal Limit” on the t:slim X2 with Control-IQ technology insulin pumps.