The FDA is aware that Tandem Diabetes Care sent all affected customers an Urgent Medical Device Correction letter for its certain t:slim X2 Insulin Pumps after identifying a potential speaker-related issue. This issue can trigger an error which will stop insulin delivery and render the pump no longer operational. The use of the affected product may result in insulin delivery stopping and missing real-time reporting of continuous glucose monitoring estimated glucose values and glucose trends, which could cause high blood sugar (hyperglycemia). In severe cases of hyperglycemia, serious adverse health consequences could occur, including the risk of intervention from a medical professional, hospitalization, or even death.
There have been 59 reported injuries and no reports of death.
What to Do
- Continue using Tandem pumps as long as they have not experienced a Malfunction 16 error, but with added precautions (see below) because the Malfunction 16 can occur at any time.
- Switch to another method of insulin delivery if a Malfunction 16 occurs and contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com to arrange for a replacement pump.
All users with affected pumps:
- Look up the pump serial number to confirm if the pump is affected.
- Be prepared with a backup method of insulin delivery as directed by a physician and as set forth in the pump training and laid out in the pump user guide.
If a Malfunction 16 hasn’t occurred:
| If a Malfunction 16 alert is received:
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- Continue using the pump as described in the User Guide, but with added precautions because Malfunction 16 can happen at any time.
- Use the Tandem t:slim mobile app with push notifications turned “ON” so if the malfunction does occur, the user receives app notification.
- See the article on Tandem’s support page for more information about setting up alerts from the mobile app.
- Dexcom sensor users should use the Dexcom mobile app as a secondary means of continuous glucose monitor alerts and alarms.
- Contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com if unable to download and use the Tandem t:slim mobile app and/or the Dexcom mobile app.
| - Promptly acknowledge it by pressing “Silence Alarm.”
- Switch to a backup method of insulin delivery as directed by a physician.
- Regularly check blood sugar to make sure there are no unexpectedly high or low readings.
Tandem Diabetes Care will release a software update to enhance early detection of speaker failure and introduce persistent vibration alerts to help reduce potential safety risk. Affected pump users will be notified by Tandem when the software update becomes available so pump users may complete the software update.
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Full details, including next steps for users with affected pumps are outlined on the FDA website.