MAUDE manufacturer profile

QIAGEN GMBH · OWD

MAUDE profile for Somatic Gene Mutation Detection System

Key facts

Manufacturer QIAGEN GMBH
Manufacturer group QIAGEN GMBH
Product code OWD
Product code name Somatic Gene Mutation Detection System

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Signal Artifact/Noise, Insufficient Information, Diarrhea, Therapeutic Response, Decreased, Hyperphosphatemia, Stomatitis, Liver Damage/Dysfunction, Keratitis 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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