MAUDE manufacturer profile
ABBOTT DIABETES CARE INC., USA · QBJ
MAUDE profile for Integrated Continuous Glucose Monitoring System, Factory Calibrated
Key facts
| Manufacturer | ABBOTT DIABETES CARE INC., USA |
|---|---|
| Manufacturer group | ABBOTT DIABETES CARE 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, Incorrect, Inadequate or Imprecise Result or Readings, Hypoglycemia, Loss of consciousness, Low Readings, Unable to Obtain Readings, Hyperglycemia, Device Displays Incorrect Message 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