BEUDAMED
    FDA Recall Open, Classified

    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-1811-2022 · Initiated May 24, 2022

    Recall

    Recall Number
    Z-1811-2022
    Event Number
    90628
    Firm
    Tandem Diabetes Care Inc
    FEI Number
    3007981285
    Product Code
    PQF
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 24, 2022
    Posted
    September 26, 2022
    Address
    11075 Roselle St, San Diego, CA, 92121-1204

    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.

    Action

    On 5/24/22, and 7/7/22, correction notices sent to customers in Australia and New Zealand 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 available with latest software versions. Software update contact: Australia, AMSL: [email protected] or 1300 851 056; New Zealand, NZMS [email protected] (Questions: 0508 634 103) On 7/26/22, correction notices were mailed or emailed in the United States to healthcare providers and distributors. Recalling firm contact: [email protected] Providers asked to instruct patients to update pump software. Software update called version 6.6.0.1 for Basal-IQ technology and version 7.6.0.1 for Control-IQ technology. Check software version on the pump: options > my pump > pump info and arrow down to software version. See user guide and to visit https://support.tandemdiabetes.com/hc/en-us/articles/1500011452302-How-do-I-check-what-software-version-is-on-my-pump-video- Latest software can be downloaded remotely from a computer. Visit https://portal.tandemdiabetes.com and login with their t:connect account credentials. Once logged in, click the MY DEVICES to view available software updates. Perform software update via the Tandem Device Updater (TDU), with precautions and instructions provided in user TDU guide: https://www.tandemdiabetes.com/docs/default-source/product-documents/tandem-device-updater/aw-1004796_c-user-guide-tandem-device-updater-5-4-artwork.pdf. Acknowledge correction notice receipt: https://go.tandemdiabetes.com/Field-Correction-Notice-X.6_US.html Distributors with impacted part numbers asked to contact the recalling firm s distribution team. On 8/4/22, users sent correction notice to update pump software. See above for acknowledgment form link and software update instructions. Prescription and training may be required if pump is out-of-warranty and not currently using Control-IQ technology, can only update to Basal-

    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

    31,100