t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Summary
The FDA issued a Class I for t:connect mobile app used in conjunction with t:slim X2 insulin pump with Contr by Tandem Diabetes Care, Inc.. Reason: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats.
Details
Source
Device Recall
External ID
Z-1609-2024
Action Date
2024-05-15
Status
Ongoing
Category
device
Product Description
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Lot/Code Info: version 2.7 or later /UDI: 00850006613274
Quantity Affected: 85,863 applications
Reason for Recall
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Distribution
US nationwide distribution including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-05
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 151 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-1609-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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