MAUDE manufacturer profile
ROCHE DIAGNOSTICS · MTF
MAUDE profile for Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | ROCHE DIAGNOSTICS GMBH |
| Product code | MTF |
| Product code name | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Low Test Results, No Consequences Or Impact To Patient, Incorrect Measurement, High Test Results, Non Reproducible Results, Incorrect, Inadequate or Imprecise Result or Readings, No Known Impact Or Consequence To Patient 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