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Recall Observatory FDA recall evidence

Device product

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

Z-1258-2022

September 10, 2020

Class II

Product summary

Firm
Tandem Diabetes Care Inc
Event
Event 90113
Status
Ongoing
Classification
Class II
Quantity
5,206
Official record key
device-enforcement:Z-1258-2022

Official wording

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.

Code information: Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier

Distribution pattern: International distribution in the country of Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.