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
- Company
- Tandem Diabetes Care Inc
- Recall Initiated
- May 24, 2022
- Posted
- September 26, 2022
- Recall Number
- Z-1812-2022
- Quantity
- 8399
- Firm Location
- San Diego, CA
Reason for Recall
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.
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
Lot / 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
Root Cause
Device Design
Action Taken
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: diabetes@amsl.com.au or 1300 851 056; New Zealand, NZMS tandemupdate@nzms.co.nz (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: Techsupport@tandemdiabetes.com 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-