MAUDE brand profile
COBAS INTEGRA 400 PLUS
MAUDE brand safety profile
Key facts
| Brand name | COBAS INTEGRA 400 PLUS |
|---|
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, High Test Results, Non Reproducible Results, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Low Test Results, Incorrect, Inadequate or Imprecise Result or Readings, Incorrect Or Inadequate Test Results 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