t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Summary
The FDA issued a Class II for t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump wit by Tandem Diabetes Care Inc. 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.
Details
Source
Device Recall
External ID
Z-1258-2022
Action Date
2022-06-22
Status
Ongoing
Category
device
Product Description
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Lot/Code Info: Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier
Quantity Affected: 5,206
Reason for Recall
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.
Distribution
International distribution in the country of Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-09-10
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 108 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-1258-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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