Definition: A Non-adjunctive Invasive Glucose Sensor Is Intended To Determine Glucose Levels, And The Direction And Rate Of Change Of Glucose Levels In People With Diabetes. The Device Is Indicated To Replace Information Obtained From Standard Blood Glucose Moni
| Device Type ID | 721 |
| Device Name | Sensor, Glucose, Invasive, Non-adjunctive |
| 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 | PQF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 721 |
| Device | Sensor, Glucose, Invasive, Non-adjunctive |
| Product Code | PQF |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Wireless Communication Problem | 76295 |
Imprecision | 49201 |
Device Displays Incorrect Message | 27839 |
Use Of Device Problem | 24337 |
Sensor | 24322 |
Transmitter | 18765 |
Receiver | 8387 |
Invalid Sensing | 6972 |
No Device Output | 4171 |
Device Inoperable | 3760 |
Defective Alarm | 3318 |
Inappropriate Or Unexpected Reset | 2889 |
Unable To Obtain Readings | 2393 |
Device Operates Differently Than Expected | 2207 |
Premature End-of-Life Indicator | 2154 |
Low Battery | 1878 |
Component Missing | 1320 |
Unexpected Shutdown | 1286 |
Detachment Of Device Or Device Component | 1088 |
Detachment Of Device Component | 982 |
No Audible Alarm | 747 |
Adverse Event Without Identified Device Or Use Problem | 639 |
Connection Problem | 534 |
Display Or Visual Feedback Problem | 479 |
Break | 414 |
Appropriate Term/Code Not Available | 370 |
Overheating Of Device | 321 |
Unintended Application Program Shut Down | 240 |
Application Program Freezes, Becomes Nonfunctional | 108 |
Output Problem | 94 |
Low Audible Alarm | 79 |
Alarm Not Visible | 48 |
Environmental Particulates | 30 |
Communication Or Transmission Problem | 28 |
Retraction Problem | 26 |
Insufficient Information | 19 |
Gel Leak | 17 |
Failure To Power Up | 16 |
Operating System Version Or Upgrade Problem | 15 |
Calibration Error | 15 |
Battery Problem | 15 |
Device Issue | 13 |
Failure To Calibrate | 12 |
Incomplete Or Inadequate Connection | 11 |
Unintended Electrical Shock | 10 |
Failure To Sense | 8 |
Date/Time-Related Software Problem | 5 |
Inappropriate Shock | 4 |
False Alarm | 3 |
Calcified | 3 |
Fire | 2 |
Activation, Positioning Or Separation Problem | 2 |
Failure To Charge | 2 |
Unintended Ejection | 2 |
Decrease In Pressure | 2 |
Improper Alarm | 2 |
Delayed Alarm | 2 |
Calibration Problem | 2 |
Device Or Device Fragments Location Unknown | 1 |
Fluid Leak | 1 |
Image Orientation Incorrect | 1 |
Device Alarm System | 1 |
Impedance Problem | 1 |
Application Program Problem | 1 |
Off-Label Use | 1 |
Receiver Stimulator Unit | 1 |
Loss Of Threshold | 1 |
Looping | 1 |
Arcing At Paddles | 1 |
Thermocouple | 1 |
Premature Discharge Of Battery | 1 |
Insufficient Cooling | 1 |
Radiofrequency Interference (RFI) | 1 |
Imager | 1 |
Device Component Or Accessory | 1 |
Wheelchair, Tires | 1 |
Issue With Displayed Error Message | 1 |
Data Problem | 1 |
Vibration | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
| Total Device Problems | 267926 |