MAUDE manufacturer profile
MEDTRONIC PUERTO RICO OPERATIONS CO. · MDS
MAUDE profile for Sensor, Glucose, Invasive
Key facts
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
|---|---|
| Manufacturer group | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Product code | MDS |
| Product code name | Sensor, Glucose, Invasive |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 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, Physical Resistance/Sticking, Calibration Problem, Unexpected Therapeutic Results, Use of Device Problem, Hyperglycemia, Hypoglycemia 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