Definition: An Integrated Continuous Glucose Monitoring System (iCGM) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. ICGM Systems Are Designed To Reliably And Securely Transmit Glucose Mea
| Device Type ID | 678 |
| Device Name | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Physical State | Glucose Sensor, A Transmitter, And A Primary Receiver. The Device Contains Software To Calculate Glucose Values. |
| Technical Method | A Transcutaneous Glucose Sensor Which Is Factory Calibrated. The Sensor Is Inserted At Home By The End User, And Is Used In Conjunction With The Associated Transmitter And Receiver To Monitor Glucose Levels For The Management Of Diabetes. |
| Target Area | Diagnostics |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1355 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 678 |
| Device | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Product Code | QBJ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1355 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEXCOM, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Wireless Communication Problem | 18606 |
Imprecision | 17337 |
Retraction Problem | 3472 |
Device Displays Incorrect Message | 3092 |
No Device Output | 2169 |
Premature End-of-Life Indicator | 2046 |
Detachment Of Device Or Device Component | 532 |
Communication Or Transmission Problem | 490 |
Defective Alarm | 349 |
Unintended Application Program Shut Down | 329 |
Appropriate Term/Code Not Available | 291 |
Unable To Obtain Readings | 180 |
Adverse Event Without Identified Device Or Use Problem | 168 |
Use Of Device Problem | 148 |
Connection Problem | 140 |
No Audible Alarm | 127 |
Unexpected Shutdown | 116 |
Sensor | 115 |
Break | 106 |
Output Problem | 93 |
Inappropriate Or Unexpected Reset | 77 |
Display Or Visual Feedback Problem | 67 |
Transmitter | 63 |
Alarm Not Visible | 46 |
Low Audible Alarm | 21 |
Application Program Freezes, Becomes Nonfunctional | 20 |
Unintended Ejection | 19 |
Receiver | 10 |
Overheating Of Device | 10 |
Incomplete Or Inadequate Connection | 10 |
Device Operates Differently Than Expected | 9 |
Unintended Electrical Shock | 9 |
Insufficient Information | 7 |
Component Missing | 6 |
Failure To Calibrate | 3 |
Activation, Positioning Or Separation Problem | 3 |
Failure To Sense | 2 |
Device Inoperable | 2 |
False Alarm | 1 |
Problem With Removal Of Enzymatic Cleaner | 1 |
Date/Time-Related Software Problem | 1 |
Arcing At Paddles | 1 |
Detachment Of Device Component | 1 |
Inaccurate Information | 1 |
Operating System Version Or Upgrade Problem | 1 |
| Total Device Problems | 50297 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Inc. | II | Sep-19-2018 |