Tandem Diabetes Care has issued an urgent correction addressing potential risks associated with certain t:slim X2 insulin pumps. Healthcare professionals, diabetes patients, and caregivers should review the details carefully to understand the implications for safety and device performance.
Which Devices Are Impacted?
The correction targets specific t:slim X2 insulin pumps that may experience a Malfunction 16 error linked to faulty speaker wiring. This issue could lead to the device stopping insulin delivery entirely. Patients can confirm whether their pump is affected by reviewing serial numbers provided at Tandem’s dedicated recall page.
What Is Malfunction 16 and Why Does It Matter?
A Malfunction 16 error can occur due to faulty wiring in the pump’s speaker system. This not only disrupts insulin delivery but also impacts the reporting of continuous glucose monitoring (CGM) values, putting users at risk for undetected high blood sugar levels (hyperglycemia). In severe cases, hyperglycemia can lead to hospitalization, professional medical intervention, or even death.
Although no fatalities have been reported, there have been 59 injuries associated with this issue.
What Action Is Tandem Diabetes Taking?
Tandem Diabetes Care plans to release a software update to improve early detection of speaker failure and enable constant vibration alerts as a backup measure. This corrective action serves to reduce safety risks without removing pumps from user environments unless a Malfunction 16 has already occurred.
Affected users will be notified when the update becomes available. In the meantime, Tandem advises users to continue using their devices cautiously, as outlined below.
What Should Users Do?
If a Malfunction 16 Has Not Occurred:
- Continue using the pump with added precautions as described in its user guide.
- Regularly check blood sugar levels to ensure readings are within a normal range.
- Enable push notifications through the Tandem t:slim mobile app for immediate alerts.
- If using a Dexcom sensor, rely on the Dexcom mobile app as a secondary alert system.
If a Malfunction 16 Occurs:
- Switch to an alternative method of insulin delivery as directed by a healthcare provider.
- Contact Tandem Diabetes Care at Techsupport@tandemdiabetes.com or call 1-877-801-6901 to arrange for a replacement device.
- Promptly acknowledge alerts generated by the pump and app systems.
FDA Classification and UDI Role
The FDA has classified this correction as its most serious recall level, indicating a risk of serious injury or death. Tandem’s serial number database and the Unique Device Identifier (UDI) system provide greater accuracy in identifying affected devices, facilitating resolution and mitigating risks.
The searchable UDI database can be accessed via AccessGUDID.
Final Takeaway for Users and Medical Professionals
All users should take precautions and stay informed about safety measures. Recognizing alerts promptly and adhering to updated guidance will help reduce risks. Clinicians should also monitor patients using t:slim X2 pumps closely and provide alternative options if needed.
Disclaimer for Professionals
This blog is for informational purposes only and does not constitute legal or clinical advice. Always refer to official FDA notifications and documents for authoritative guidance.