‘Urgent’ Device Correction Issued for Tandem Insulin Pump

[Northerner]

Tandem Diabetes Care has sent an “Urgent Medical Device Correction” letter to potentially affected users of the t:slim X2 insulin pump, cautioning that the pump’s speaker could fail, causing insulin delivery to stop.

Certain versions of the pump’s speaker were found to have a wiring issue that leads to higher than usual rates of a specific type of malfunction (“Malfunction 16”). That, in turn, causes the pump to stop delivering insulin and terminates communication between the pump and the continuous glucose monitor, as well as the t:slim mobile app. If not addressed, severe hyperglycemia could result.

As of July 22, 2025, the date of the letter, there had been 700 reports of adverse events and 59 reported injuries but no deaths.

‘Urgent’ Device Correction Issued for Tandem Insulin Pump

Tandem Diabetes Care sent an ‘Urgent Medical Device Correction’ letter regarding possible speaker failure and pump delivery failure.

www.medscape.com

Presumably applies to UK pumps as well

 

[everydayupsanddowns]

Yikes!

Not sure why having a glitch in the speaker should cause the pump to stop insulin delivery, but the tSlim does seem to like stopping delivery in ways that other pumps don’t.

If I underestimate my insulin use and get down to zero units, the MM780G will complain, but continue to deliver what little dregs of insulin it has in the nearly empty reservoir (which can be more than 10u to be honest!).

When the tSlim gets to zero on its readout, it just stops. Even though there is definitely some insulin left in the ‘empty’ reservoir.

 

[martindt1606]

You would have thought that the inability of the Tslim Pump to keep time would have resulted in a software update / correction. An incorrect time can cause issues - incorrect bolus / basal calculations, incorrect start / end of sleep mode....
Lost count of the number of times I've mentioned it to Air Liquide in the last 5/6 years. Just checked and currently 10 minutes slow. Last changed when BST started...