MAUDE manufacturer profile
BECKMAN COULTER · JJE
MAUDE profile for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Key facts
| Manufacturer | BECKMAN COULTER |
|---|---|
| Manufacturer group | BECKMAN COULTER MISHIMA K.K. |
| Product code | JJE |
| Product code name | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, High Test Results, Low Test Results, No Consequences Or Impact To Patient, Incorrect, Inadequate or Imprecise Result or Readings, No Known Impact Or Consequence To Patient, No Patient Involvement, Leak/Splash 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