MAUDE manufacturer profile
DEXCOM, INC. · MDS
MAUDE profile for Sensor, Glucose, Invasive
Key facts
| Manufacturer | DEXCOM, INC. |
|---|---|
| Manufacturer group | DEXCOM, INC. |
| Product code | MDS |
| Product code name | Sensor, Glucose, Invasive |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Device Operates Differently Than Expected, Device Displays Incorrect Message, Wireless Communication Problem, Invalid Sensing, Use of Device Problem, No Audible Alarm, No Known Impact Or Consequence To Patient 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