MAUDE manufacturer profile
DEXCOM, INC. · OYC
MAUDE profile for Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Key facts
| Manufacturer | DEXCOM, INC. |
|---|---|
| Manufacturer group | DEXCOM, INC. |
| Product code | OYC |
| Product code name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Wireless Communication Problem, No Consequences Or Impact To Patient, Imprecision, Device Displays Incorrect Message, Device Operates Differently Than Expected, Communication or Transmission Problem, Incorrect Measurement 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