MAUDE manufacturer profile

ROCHE DIAGNOSTICS · JQP

MAUDE profile for Calculator/Data Processing Module, For Clinical Use

Key facts

Manufacturer ROCHE DIAGNOSTICS
Manufacturer group ROCHE INSTRUMENT CENTER AG TEGIMENTA
Product code JQP
Product code name Calculator/Data Processing Module, For Clinical Use

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Application Program Problem, High Test Results, No Known Impact Or Consequence To Patient, Patient Data Problem, Computer Software Problem, No Patient Involvement 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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