Definition: An Insulin-only Automated Insulin Dosing System That Achieves A Target Glucose Level By Automatically Increasing Or Reducing Insulin Infusion From An Insulin Pump. Insulin Adjustments Are Based Upon Specified Thresholds Of Measured Glucose Levels.
| Device Type ID | 714 |
| Device Name | Automated Insulin Dosing Device System, Single Hormonal Control |
| Physical State | May Include: Continuous Glucose Monitoring System, Sensor, Self Monitoring Blood Glucose Device, Infusion Pump, Data Management Software |
| Technical Method | Uses A Glucose Monitoring System To Measure Glucose Levels And Increases Or Reduces Insulin Infusion From An Insulin Pump |
| Target Area | Not Meant To Act On A Specific Part Of The Body But Works With Other Devices - Continuous Glucose Monitoring System, Sensor, Self Monitoring Blood Glucose Device, Data Management Software |
| 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 | OZP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 714 |
| Device | Automated Insulin Dosing Device System, Single Hormonal Control |
| Product Code | OZP |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 6827 |
No Apparent Adverse Event | 5339 |
Patient Device Interaction Problem | 3965 |
Appropriate Term/Code Not Available | 3248 |
Device Alarm System | 1746 |
No Display / Image | 1618 |
Device Difficult To Program Or Calibrate | 1070 |
Connection Problem | 1037 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1000 |
Circuit Failure | 891 |
Power Problem | 820 |
Display Or Visual Feedback Problem | 730 |
Mechanical Problem | 587 |
Communication Or Transmission Problem | 492 |
Computer Software Problem | 474 |
Obstruction Of Flow | 437 |
Calibration Problem | 426 |
Unexpected Therapeutic Results | 377 |
Moisture Or Humidity Problem | 330 |
Material Integrity Problem | 239 |
Insufficient Flow Or Under Infusion | 202 |
Excess Flow Or Over-Infusion | 155 |
Visual Prompts Will Not Clear | 143 |
Human-Device Interface Problem | 133 |
Mechanical Jam | 122 |
Electrical /Electronic Property Problem | 106 |
Break | 81 |
Loss Of Data | 76 |
Battery Problem | 67 |
Intermittent Loss Of Power | 61 |
Failure Of Device To Self-Test | 58 |
Unintended Movement | 56 |
Date/Time-Related Software Problem | 47 |
Fracture | 47 |
Priming Problem | 42 |
Difficult To Remove | 37 |
Insufficient Information | 35 |
Device Markings / Labelling Problem | 35 |
Intermittent Communication Failure | 28 |
Overheating Of Device | 20 |
Manufacturing, Packaging Or Shipping Problem | 19 |
Material Twisted / Bent | 13 |
Use Of Device Problem | 9 |
Activation Problem | 3 |
Application Program Problem: Medication Error | 2 |
Environmental Compatibility Problem | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Calibration Error | 1 |
Fluid Leak | 1 |
Inaccurate Delivery | 1 |
Incorrect Measurement | 1 |
Failure To Calibrate | 1 |
Activation, Positioning Or Separation Problem | 1 |
Tip | 1 |
Device Displays Incorrect Message | 1 |
Infusion Or Flow Problem | 1 |
| Total Device Problems | 33261 |