{"schema_version":"secwatch.filing_event.v1","accession":"0001438133-24-000088","form_type":"8-K","ticker":"TNDM","cik":"0001438133","company_name":"TANDEM DIABETES CARE INC","filed_at":"2024-05-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.428200+00:00","generated_at":"2026-06-01T19:53:15.175597+00:00","sec_items":["1.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.35,"calibrated_materiality_score":0.35,"confidence":"medium","headline":"Tandem obtains Health Canada approval for Trurapi U-100 compatibility with t:slim X2 pump","bullets":["Health Canada approved adding Trurapi U-100 to compatible insulins list for t:slim X2 with Control-IQ in Canada.","Amended distributor agreement with Unomedical extends term and revises definitions, manufacturing, and purchase terms.","Amendment details to be filed in Q2 2024 10-Q; no financial impact disclosed."],"urls":{"canonical":"https://secwatch.observer/filing/0001438133-24-000088","json":"https://secwatch.observer/filing/0001438133-24-000088.json","markdown":"https://secwatch.observer/filing/0001438133-24-000088.md","text":"https://secwatch.observer/filing/0001438133-24-000088.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438133/000143813324000088/0001438133-24-000088-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438133/000143813324000088/tndm-20240510.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T19:53:15.175597+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[{"claim_id":"f071f9e4824d89f19584b71365e9a25d21791a54","claim":"TANDEM DIABETES CARE INC amended Amendment Number 1 with Unomedical a/s (effective 2024-05-10).","evidence_excerpt":"On May 10, 2024, Tandem Diabetes Care, Inc., a Delaware corporation (the “Company”) and Unomedical a/s, a Danish corporation and a subsidiary of the ConvaTec Group (“Unomedical”), entered into Amendment Number 1 (“Amendment 1”) to the Distributor Agreement, dated as of January 14, 2022, between the Company and Unomedical, under which Unomedical manufactures, tests, sterilizes and packs all of the infusion sets under the Company’s brands (the “Original Agreement”).","evidence_source":"SEC 8-K Item 1.01/1.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1438133/000143813324000088/0001438133-24-000088-index.htm","confidence":0.9,"family_label":"Material Agreements","details":[{"label":"Action","value":"amendment"},{"label":"Agreement","value":"supply"},{"label":"Counterparty","value":"Unomedical a/s"},{"label":"Effective","value":"2024-05-10"}],"fact_type":"material_agreement"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}