MAUDE manufacturer profile
DEXCOM, INC. · QBJ
MAUDE profile for Integrated Continuous Glucose Monitoring System, Factory Calibrated
Key facts
| Manufacturer | DEXCOM, INC. |
|---|---|
| Manufacturer group | DEXCOM, INC. |
| Product code | QBJ |
| Product code name | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
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 Clinical Signs, Symptoms or Conditions, Wireless Communication Problem, No Device Output, No Consequences Or Impact To Patient, Detachment of Device or Device Component, Imprecision, Hyperglycemia, Premature End-of-Life Indicator 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