MAUDE manufacturer profile

SIEMENS HEALTHCARE DIAGNOSTICS INC. · NIG

MAUDE profile for System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Key facts

Manufacturer SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer group SIEMENS HEALTHCARE DIAGNOSTICS INC.
Product code NIG
Product code name System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic 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, High Test Results, No Known Impact Or Consequence To Patient, No Apparent Adverse Event, Adverse Event Without Identified Device or Use Problem, Low Test Results, No Consequences Or Impact To Patient, Off-Label Use 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

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