BEUDAMED
    FDA Enforcement Class II Ongoing

    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology

    Recall: Z-1812-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1812-2022
    Event ID
    90628
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tandem Diabetes Care Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    May 24, 2022
    Classification Date
    September 26, 2022
    Address
    11075 Roselle St, N/A, San Diego, CA, 92121-1204, United States

    Description

    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology

    Reason

    Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.

    Code Info

    Insulin Pump/Software Versions: t:slim X2 insulin pump/6.4.1 and earlier; t:slim X2 insulin pump with Dexcom G5/5.2.1, 5.2.2; t:slim X2 insulin pump with Basal-IQ technology/6.3.0.1, 6.4, 6.4.1; t: slim x2 insulin pump with the Control-IQ Technology/7.4, 7.4.3

    Distribution

    US: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC, MS, GA, NV, HI, MN, WA, IN, AR, ID, CO, IA, MO, MT, PA, WI, NH, MD, WV, KS, NM, OR, KY, DE, ND, CT, NJ, TN, WY, AK, SD, DC, RI, IA, PR, VT, PT, VI, NC. OUS: Australia, New Zealand, South Africa

    Quantity

    8399