Definition: The Device Is A Glucose-monitoring Device Indicated For Detecting Trends And Tracking Patterns In Adults (age 18 And Older) With Diabetes. The Device Is Indicated For Use As An Adjunctive Device To Complement, Not Replace, Information Obtained From S
| Device Type ID | 705 |
| Device Name | Sensor, Glucose, Invasive |
| 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 | MDS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 705 |
| Device | Sensor, Glucose, Invasive |
| Product Code | MDS |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 45666 |
Wireless Communication Problem | 41276 |
Device Operates Differently Than Expected | 30626 |
Invalid Sensing | 25631 |
Use Of Device Problem | 17206 |
No Audible Alarm | 10869 |
Defective Alarm | 5997 |
Imprecision | 5443 |
Inappropriate Or Unexpected Reset | 3203 |
Sensor | 2574 |
Device Inoperable | 2543 |
Receiver | 2222 |
Adverse Event Without Identified Device Or Use Problem | 2122 |
Detachment Of Device Component | 1637 |
Component Missing | 1328 |
Transmitter | 997 |
Structural Problem | 783 |
Display Or Visual Feedback Problem | 564 |
Unable To Obtain Readings | 540 |
Image Display Error / Artifact | 321 |
Break | 310 |
Overheating Of Device | 280 |
Low Battery | 277 |
Unexpected Shutdown | 274 |
Fail-Safe Problem | 172 |
Failure To Power Up | 166 |
Detachment Of Device Or Device Component | 124 |
Appropriate Term/Code Not Available | 100 |
No Display / Image | 95 |
Data Problem | 89 |
No Device Output | 89 |
Electrical /Electronic Property Problem | 88 |
Moisture Damage | 85 |
Incorrect Measurement | 80 |
Failure To Read Input Signal | 69 |
Premature End-of-Life Indicator | 59 |
Operating System Version Or Upgrade Problem | 53 |
Communication Or Transmission Problem | 52 |
Premature Discharge Of Battery | 50 |
Retraction Problem | 48 |
Device Issue | 43 |
Failure To Prime | 40 |
Output Problem | 36 |
Fracture | 35 |
Low Audible Alarm | 25 |
Connection Problem | 24 |
Failure To Charge | 20 |
Failure To Sense | 17 |
Failure To Adhere Or Bond | 16 |
Device Stops Intermittently | 14 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 14 |
Inaccurate Delivery | 13 |
Temperature Problem | 12 |
Improper Or Incorrect Procedure Or Method | 12 |
Bent | 10 |
Device Alarm System | 10 |
Mechanical Problem | 9 |
Device Operational Issue | 9 |
Battery Problem | 9 |
Self-Activation Or Keying | 9 |
Intermittent Continuity | 8 |
Display | 8 |
Crack | 8 |
Insufficient Information | 8 |
Needle | 7 |
Improper Device Output | 7 |
Date/Time-Related Software Problem | 7 |
Incorrect Or Inadequate Test Results | 6 |
Poor Quality Image | 6 |
Partial Blockage | 6 |
Incomplete Or Inadequate Connection | 5 |
Improper Alarm | 5 |
Alarm Not Visible | 5 |
Device Handling Problem | 5 |
Computer Hardware | 5 |
Calibration Error | 5 |
No Audible Prompt / Feedback | 5 |
Vibration | 5 |
Device Sensing Problem | 5 |
Cannula | 5 |
Antenna | 4 |
Issue With Displayed Error Message | 4 |
Power Problem | 4 |
Loss Of Data | 4 |
Human Factors Issue | 4 |
Environmental Particulates | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Inappropriate Shock | 3 |
Charging Problem | 3 |
Unintended Application Program Shut Down | 3 |
False Reading From Device Non-Compliance | 3 |
Screen | 3 |
Wire | 3 |
High Test Results | 2 |
High Readings | 2 |
Occlusion Within Device | 2 |
No Apparent Adverse Event | 2 |
Difficult To Remove | 2 |
Inaccurate Synchronization | 2 |
Computer Operating System Problem | 2 |
| Total Device Problems | 204664 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Dexcom Inc | I | Apr-11-2016 |
| 2 | Medtronic MiniMed Inc. | II | Aug-21-2015 |
| 3 | Medtronic MiniMed Inc. | II | Aug-10-2014 |