510(k) K210943— FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Substantially Equivalent

Abbott Diabetes Care, Inc.

Clearance details

Applicant: Abbott Diabetes Care, Inc.
Product code: Code QLG
Advisory panel: Clinical Chemistry
Date received: 2021-03-30
Decision date: 2021-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Adverse events under product code QLG

product code QLG

Death: 27
Injury: 40,773
Malfunction: 107,857
Other: 6
Total: 148,663

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.