Integrated Continuous Glucose Monitoring System, Factory Calibrated

Device Code: 678

Product Code(s): QBJ

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 Classification Information

Device Type ID678
Device NameIntegrated Continuous Glucose Monitoring System, Factory Calibrated
Physical StateGlucose Sensor, A Transmitter, And A Primary Receiver. The Device Contains Software To Calculate Glucose Values.
Technical MethodA 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 AreaDiagnostics
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1355 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeQBJ
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID678
DeviceIntegrated Continuous Glucose Monitoring System, Factory Calibrated
Product CodeQBJ
FDA Device ClassificationClass 2 Medical Device
CFR Regulation Number862.1355 [🔎]
Premarket Reviews
ManufacturerDecision
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
TPLC Last Update: 2019-04-02 19:38:33

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