Definition: A Subcutaneous Factory Calibrated, Non-adjunctive, Invasive, Passive Monitoring Glucose Sensor Is Intended To Determine Glucose Levels And The Direction And Rate Of Change Of Glucose Levels In People With Diabetes. Calibrated At The Point Of Manufact
| Device Type ID | 722 |
| Device Name | Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated |
| Physical State | This Device Comprises A Skin Piercing Sensor Containing The Glucose Specific Biological Sensor, An Algorithm That Converts Sensor Signals Into Glucose Values, A Display Device Which Provides Glucose Values To The User And A Mechanism For Transmitting |
| Technical Method | Signals From An Invasive (skin Piercing) Glucose Specific Biological Sensor Are Algorithmically Converted To Glucose Values Which Are Provided To The User. |
| Target Area | Interstitial Fluid. |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PZE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 722 |
| Device | Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated |
| Product Code | PZE |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 1541 |
High Readings | 303 |
Low Readings | 249 |
Device Displays Incorrect Message | 210 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 129 |
Detachment Of Device Or Device Component | 73 |
No Display / Image | 18 |
No Device Output | 16 |
Failure To Power Up | 15 |
Product Quality Problem | 15 |
Battery Problem | 5 |
Insufficient Information | 5 |
Failure To Fire | 4 |
Display Or Visual Feedback Problem | 3 |
Unable To Obtain Readings | 3 |
Data Problem | 2 |
Fire | 2 |
Missing Test Results | 2 |
Misfire | 2 |
Premature Discharge Of Battery | 1 |
Melted | 1 |
Smoking | 1 |
Sparking | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Thermal Decomposition Of Device | 1 |
Premature End-of-Life Indicator | 1 |
Under-Sensing | 1 |
Detachment Of Device Component | 1 |
Image Display Error / Artifact | 1 |
| Total Device Problems | 2608 |