SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. The error, which appears as a Malfunction 16 alarm to the user, will stop insulin delivery and terminate communication between the insulin pump and the continuous glucose monitoring (CGM) device. If not addressed, this
Related Questions
How might the voluntary correction impact Tandem's revenue forecasts for the current quarter and the remainder of the year?
What is the estimated number of t:slim X2 pumps affected by this correction and the associated financial cost to Tandem Diabetes Care?
What steps is Tandem taking to mitigate supply chain disruptions and prevent future device malfunctions?
How does this recall compare in scale and severity to recent recalls in the diabetes device sector, such as those involving Medtronic or Dexcom?
Are there any potential liability or classâaction lawsuits emerging from users who experienced insulin delivery interruptions?
Could this issue influence investor sentiment toward the broader diabetes management market, potentially impacting related stocks or ETFs?
Is there any indication that this correction will lead to a revision of Tandem's guidance or affect its upcoming earnings call?
How will the correction affect Tandem's relationship with its CGM partners and the continuity of integrated therapy solutions?
Will the FDA require additional regulatory filings or approvals due to this correction, and could that affect the timeline for future product launches?
What is the expected market reaction to the -55 sentiment rating, and could it trigger shortâselling activity or a broader sellâoff in the medâtech space?