FDA 483 - Tandem Diabetes Care, Inc. - October 15, 2021

Tandem Diabetes Care Inc. in San Diego, CA, was cited for significant deficiencies in its quality system related to its diabetes infusion pumps. The firm failed to report a critical correction of a health risk to the FDA, inadequately established corrective and preventive actions for serious device malfunctions and design flaws, and neglected to investigate numerous complaints involving device failures. Additionally, the firm's risk analysis for its t:slim X2 infusion pump was found to be incomplete, failing to adequately assess patient risks, including those that led to patient deaths.