MAUDE manufacturer profile
MEDTRONIC PUERTO RICO OPERATIONS CO. · OZO
MAUDE profile for Automated Insulin Dosing, Threshold Suspend
Key facts
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
|---|---|
| Manufacturer group | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Product code | OZO |
| Product code name | Automated Insulin Dosing , Threshold Suspend |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Hyperglycemia, No Clinical Signs, Symptoms or Conditions, Break, Patient Device Interaction Problem, Adverse Event Without Identified Device or Use Problem, Device Displays Incorrect Message, No Display/Image 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