MAUDE manufacturer profile
DEXCOM INC. · PQF
MAUDE profile for Sensor, Glucose, Invasive, Non-Adjunctive
Key facts
| Manufacturer | DEXCOM INC. |
|---|---|
| Manufacturer group | DEXCOM, INC. |
| Product code | PQF |
| Product code name | Sensor, Glucose, Invasive, Non-Adjunctive |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Wireless Communication Problem, Imprecision, Device Displays Incorrect Message, No Device Output, Use of Device Problem, Invalid Sensing, No Clinical Signs, Symptoms or Conditions 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