MAUDE manufacturer profile
SIEMENS HEALTHCARE DIAGNOSTICS INC. · PDJ
MAUDE profile for Hemoglobin A1c Test System
Key facts
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Manufacturer group | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | PDJ |
| Product code name | Hemoglobin A1c Test System |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Incorrect Or Inadequate Test Results, High Test Results, 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