Online Seller, pnokia.com
12 hours ago •reported by user-nzyz7368 • details
Sell stuff on cheaper price but scamming people with garbage.
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Safety Report: Tandem iOS Mobile App - recalled due to Insulin Pump Battery Issue, USA
1 month ago •source fda.gov
Recall notice
United States
Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience following the release of version 2.7.1 of the app in March. Under-delivery of insulin because of a pump shutdown can result in hyperglycemia or diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugar and lack of insulin. There have been 107 confirmed adverse events with this recall. Adverse events are defined as a confirmed high blood sugar and/or an event requiring medical intervention. Two hospitalizations and no deaths have been reported.Recommendations for Impacted t:slim X2 Pump Users Tandem strongly recommends anyone using the Apple iOS t:connect Mobile App with a t:slim X2 insulin pump to do the following:
- Continue using your Tandem pump and t:connect mobile app as described in the User Guide:
a) Charge the pump for a short time every day (10 to 15 minutes) to avoid frequent full battery discharges.
b) Monitor pump battery levels closely to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown.
c) Always carry back-up supplies.
- If a low battery alert is received, Tandem strongly recommends charging the device as soon as possible.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Tandem Diabetes Care, Inc.
Brand name: Tandem
Product recalled: T:Connect Mobile App for iOS Devices
Reason of the recall: Rapid Depletion of a User’s t:slim X2 Insulin Pump Battery
FDA Recall date: August 12, 2024
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tandem-diabetes-care-provides-update-march-2024-nationwide-recall-tconnect-mobile-app-ios-devices
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