MAUDE manufacturer profile

MEDTRONIC MINIMED · OZP

MAUDE profile for Automated Insulin Dosing Device System, Single Hormonal Control

Key facts

Manufacturer MEDTRONIC MINIMED
Manufacturer group MEDTRONIC MINIMED
Product code OZP
Product code name Automated Insulin Dosing Device System, Single Hormonal Control

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Wireless Communication Problem, Incorrect, Inadequate or Imprecise Result or Readings, Communication or Transmission Problem, Calibration Problem, Battery Problem, Hyperglycemia, Unexpected Therapeutic Results 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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