Recall Z-1258-2022 ยท PQF Sensor, Glucose, Invasive, Non-Adjunctive
Tandem Diabetes Care Inc
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
| Date | Jun 10, 2022 (initiated Sep 10, 2020) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 displ |
| Quantity | 5,206 |
| Distribution | International distribution in the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.