Regulatory information

Regulatory information

The t:slim X2 Insulin Pump is CE marked as a class IIb medical device. It received its CE mark in 2018.

The following manufacturer field safety notices or medical device alerts for this technology have been identified:

  • A Medicines and Healthcare products Regulatory Agency Medical Device Alert for t:slim X2 insulin pump. This alert was for faulty mains (A/C) power adaptors. The users of the affected pumps were identified, and adaptors were replaced.

  • Further safety concerns have been identified through the Manufacturer and User Facility Device Experience database. These include pumps turning off and becoming unresponsive or failing to charge, tubing failing to fill with insulin, a person having too much insulin delivered, and insulin and battery gauges being reported as inaccurate.

  • Brown et al. (2019) noted that the use of the Control‑IQ software was temporarily suspended during the study (in March 2019). This was because of a software error leading to insulin delivery stopping for several hours, or an incorrect bolus being given when insulin delivery restarted. However, this did not lead to any serious adverse events and was rectified. This study also reported 1 instance of diabetic ketoacidosis and 12 instances of hyperglycaemia or ketosis without diabetic ketoacidosis in the group using the t:slim X2 insulin pump.