t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim
Summary
The FDA issued a Class II for t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin by Tandem Diabetes Care Inc. Reason: Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen St.
Details
Source
Device Recall
External ID
Z-1812-2022
Action Date
2022-10-05
Status
Ongoing
Category
device
Product 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
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
Quantity Affected: 8399
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-24
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tandem Diabetes Care Inc has 22 FDA actions in our database, including 11 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tandem Diabetes Care Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tandem Diabetes Care Inc have FDA actions?
Tandem Diabetes Care Inc has 22 FDA actions in our database, including 11 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1812-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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