MAUDE manufacturer profile
ABBOTT DIABETES CARE INC · PZE
MAUDE profile for Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
Key facts
| Manufacturer | ABBOTT DIABETES CARE INC |
|---|---|
| Manufacturer group | ABBOTT DIABETES CARE, INC. |
| Product code | PZE |
| Product code name | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated |
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
- Incorrect, Inadequate or Imprecise Result or Readings, No Clinical Signs, Symptoms or Conditions, Hypoglycemia, Loss of consciousness, No Known Impact Or Consequence To Patient, Appropriate Term/Code Not Available, Device Displays Incorrect Message, Unable to Obtain Readings 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