MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS · MMI
MAUDE profile for Immunoassay Method, Troponin Subunit
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
|---|---|
| Manufacturer group | ORTHO CLINICAL DIAGNOSTICS |
| Product code | MMI |
| Product code name | Immunoassay Method, Troponin Subunit |
At a glance
- 1,000+ MAUDE reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- High Test Results, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Non Reproducible Results, No Consequences Or Impact To Patient, Incorrect, Inadequate or Imprecise Result or Readings, Low Test Results, High Readings Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1