MAUDE manufacturer profile
ROCHE DIAGNOSTICS · CHI
MAUDE profile for Lipase-Esterase, Enzymatic, Photometric, Lipase
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | ROCHE DIAGNOSTICS GMBH |
| Product code | CHI |
| Product code name | Lipase-Esterase, Enzymatic, Photometric, Lipase |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, High Test Results, Non Reproducible Results, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Incorrect, Inadequate or Imprecise Result or Readings, Low Test Results, Device Difficult to Setup or Prepare 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