{"schema_version":"secwatch.filing_event.v1","accession":"0001093557-25-000047","form_type":"8-K","ticker":"DXCM","cik":"0001093557","company_name":"DEXCOM INC","filed_at":"2025-03-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:02.909828+00:00","generated_at":"2026-05-25T02:55:54.611306+00:00","sec_items":["7.01","8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"DexCom receives FDA warning letter for manufacturing deficiencies; reaffirms FY2025 revenue guidance","bullets":["FDA warning letter cites non-conformities in manufacturing processes and quality systems at San Diego and Mesa facilities.","Inspections occurred Oct–Nov 2024 (San Diego) and June 2024 (Mesa); company had submitted Form 483 responses.","Warning letter does not restrict production, distribution, or 510(k) clearance; no recall required.","DexCom expects no material impact on manufacturing capacity or FY2025 revenue guidance issued Feb 13, 2025.","Company is preparing written response and intends corrective actions; resolution timeline uncertain."],"urls":{"canonical":"https://secwatch.observer/filing/0001093557-25-000047","json":"https://secwatch.observer/filing/0001093557-25-000047.json","markdown":"https://secwatch.observer/filing/0001093557-25-000047.md","text":"https://secwatch.observer/filing/0001093557-25-000047.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1093557/000109355725000047/0001093557-25-000047-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1093557/000109355725000047/dxcm-20250304.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T02:55:54.611306+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":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}