BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1258-2022 · Reported June 22, 2022

    Enforcement

    Recall Number
    Z-1258-2022
    Event ID
    90113
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tandem Diabetes Care Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2022
    Initiation Date
    September 10, 2020
    Classification Date
    June 10, 2022
    Address
    11075 Roselle St, San Diego, CA, 92121-1204, United States

    Description

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

    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 Info

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

    Distribution

    International distribution in the country of Australia.

    Quantity

    5,206