t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

FDA device recall Z-1258-2022 · posted 2022-06-10 · Open, Classified

Recall details

Recalling firm

Tandem Diabetes Care Inc

Reason for recall

Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.

Action taken

On 09/10/2020, correction notices were sent to customers who were asked to acknowledge Low Power Alerts and Low Power Alarms by tapping "OK" and then charging the pump. Further, take the following precautions to ensure that your pump is properly charged, and the pump's battery life does not fall below 25% remaining power: - Periodically check the battery level indicator of your pump - Charge the pump for a short period of time every day (10 to 15 minutes) - Avoid full battery discharges A software update is planned by the end of 2020 that resolves the potential fluctuating battery life display. We will reach out to you to complete the free remote update of your insulin pump when the software update becomes available. Complete a online form to confirm that you have received this important user communication. Customers with questions were encouraged to contact diabetes@amsl.com.au In November 2020 software version 6.4.1 was released for all affected insulin pumps except Dexcom G5 Mobile CGM system pumps. On 12/06/2020, Dexcom G5 Mobile CGM system customers were informed that a new software update was available to address the battery issues but that the update requires using the Dexcom G6 CGM system. On 5/24/22, correction notices were sent to customers in Australia to update to the latest software. t:slim X2 insulin pump with Basal-IQ technology version 6.6 and Control-IQ technology version 7.6 are available with the latest software versions. Software update contact: AMSL: diabetes@amsl.com.au or 1300 851 056.

Root cause

Software design

Status

Open, Classified

Product code

PQF

Quantity affected

5,206

Distribution

International distribution in the country of Australia.

Date initiated

2020-09-10

Date posted

2022-06-10

Location

San Diego, CA