07 June 2022
URGENT PRODUCT CORRECTION
Tandem t:slim X2™ Insulin Pump Version 5.2.2 or earlier
Tandem t:slim X2™ Insulin Pump with Basal-IQ Technology Version 6.4.1 or earlier
Medsafe Reference: 29472
Dear Customer,
New Zealand Medical & Scientific Ltd (NZMS) is issuing a product correction letter for Tandem Diabetes Care™ t: slim X2™ Insulin Pump. You are receiving this notification because our records indicate that you may be using a Tandem Diabetes Care™ t:slim X2™ insulin pump with a software version of 6.4.1 or prior. Because your safety is our top priority, we are alerting you of potential risks when using your pump within its normal specifications, as well as the availability of a software update to mitigate the potential risks. The software update also provides additional product enhancements.
What are the issues?
The new software for Tandem Diabetes Care insulin pumps mitigates the following issues. While uncommon, each of these could result in an unexpected disruption to insulin delivery:
Malfunction 6 Non-Volatile Memory (NVM):
Malfunction 6 is a malfunction that is declared when memory corruption is detected, or the memory cannot be written to or read from. The pump will declare a malfunction if a system error is detected. When this happens, the pump annunciates 3 sequences of 3 notes at the highest volume and 3 vibrations every 3 minutes until the user has acknowledged the malfunction by silencing the alarm. When a malfunction occurs, all insulin deliveries are stopped.
Inaccurate Battery Life Display while Charging the Pump:
If the pump experiences a fluctuation of the battery life display, resulting in an artificially low estimate of battery life while the battery is fully charged and plugged into a power source, a Power Source Alert will exhibit, preventing the user from charging their pump. If the alert is not noticed and the battery depletes, the pump will shut down with the appropriate low battery alerts/alarms, stopping all insulin deliveries.
Touchscreen Staying On:
If the pump’s touchscreen senses something continuously touching the screen, the pump’s software resets the display screen timeout timer causing the screen to stay on indefinitely resulting in the battery depleting faster than expected. If the battery depletes, the pump will eventually shut down with the appropriate low battery alerts/alarms, stopping all insulin deliveries.
For all three issues, the result will be an under-delivery of insulin, which could result in hyperglycaemia. In severe cases of hyperglycaemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.
What does this mean?
You can continue using your Tandem pump as described in the User Guide. It is advised to have an alternate means of insulin therapy available.
Please update your pump to the latest software version at the earliest possible opportunity.
Tandem has made available the t:slim X2™ insulin pump with Basal-IQ technology version 6.6 and Control-IQ technology version 7.6 which incorporates changes made to the software to mitigate the issues outlined above.
Please contact NZMS by emailing tandemupdate@nzms.co.nz to arrange for an update of your pump’s software.
If you have any questions, our Technical Support team can be reached on 0508 634 103.
This Product Correction is being taken by NZMS after consultation with Medsafe, Ministry of Health, New Zealand.
