MAUDE brand profile
SENSOR ENLITE
MAUDE brand safety profile
Key facts
| Brand name | SENSOR ENLITE |
|---|
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Hyperglycemia, No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, Incorrect, Inadequate or Imprecise Result or Readings, Component Missing, Hypoglycemia, Incorrect Or Inadequate Test Results, Device Operates Differently Than Expected Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1