MAUDE manufacturer profile
ROCHE DIAGNOSTICS · GJS
MAUDE profile for Test, Time, Prothrombin
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | ROCHE DIAGNOSTICS GMBH |
| Product code | GJS |
| Product code name | Test, Time, Prothrombin |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- High Test Results, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Non Reproducible Results, Low Test Results, No Known Impact Or Consequence To Patient, Image Display Error/Artifact 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