MAUDE manufacturer profile
TANDEM DIABETES CARE · OZO
MAUDE profile for Automated Insulin Dosing, Threshold Suspend
Key facts
| Manufacturer | TANDEM DIABETES CARE |
|---|---|
| Manufacturer group | DEXCOM, INC. |
| Product code | OZO |
| Product code name | Automated Insulin Dosing , Threshold Suspend |
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 Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Pumping Stopped, No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, Incorrect Measurement, Charging Problem, Obstruction of Flow 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