Automated Insulin Dosing , Threshold Suspend

Device Code: 713

Product Code(s): OZO

Definition: An Automated Insulin Dosing System That Temporarily Suspends Or Reduces Insulin Infusion From An Insulin Pump Based Upon Specified Thresholds Of Measured Glucose Levels.

Device Classification Information

• Device Type ID: 713
• Device Name: Automated Insulin Dosing , Threshold Suspend
• 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 In Interstitial Fluid Or Blood And Suspends 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 Managment 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: OZO
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 13-81 IEEE Std 11073-10419:2015
  Health Informatics - Personal Health Device Communication - Part 10419: Device Specialization - Insulin Pump
• 13-88 IEEE ISO 11073-10417 Third Edition 2017-04
  Health Informatics - Personal Health Device Communication - Part 10417: Device Specialization - Glucose Meter
• 13-90 IEEE Std 11073-10417-2015
  Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
• 13-91 IEEE ISO 11073-10419 First Edition 2016-06-15
  Health Informatics - Personal Health Device Communication - Part 10419: Device Specialization - Insulin Pump

Total Product Life Cycle

• Device Type ID: 713
• Device: Automated Insulin Dosing , Threshold Suspend
• Product Code: OZO
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	5382
Patient Device Interaction Problem	4449
No Apparent Adverse Event	4024
Device Displays Incorrect Message	2994
No Display / Image	2718
Power Problem	2396
Obstruction Of Flow	2207
Appropriate Term/Code Not Available	1931
Mechanical Problem	1900
Incorrect, Inadequate Or Imprecise Result Or Readings	1608
Device Difficult To Program Or Calibrate	1581
Display Or Visual Feedback Problem	961
Device Alarm System	854
Pumping Stopped	746
Connection Problem	744
Break	649
Failure To Cycle	638
Incorrect Measurement	629
Priming Problem	595
Switch, Push Button	595
Battery Problem	580
Device Operates Differently Than Expected	559
Device Inoperable	517
Sensor	452
Moisture Or Humidity Problem	452
Crack	451
Unexpected Therapeutic Results	408
Keypad	405
Detachment Of Device Or Device Component	388
Material Integrity Problem	351
Insufficient Flow Or Under Infusion	336
Visual Prompts Will Not Clear	314
Wireless Communication Problem	307
Communication Or Transmission Problem	275
Use Of Device Problem	272
Calibration Problem	266
Filling Problem	265
Premature Discharge Of Battery	260
Failure To Sense	260
Charging Problem	248
Circuit Failure	237
Cannula	196
Insufficient Information	195
Component Missing	177
Device Sensing Problem	163
Bent	158
Excess Flow Or Over-Infusion	157
Human-Device Interface Problem	156
Data Problem	136
Screen	131
Incorrect Or Inadequate Test Results	131
False Alarm	127
Physical Resistance / Sticking	122
Date/Time-Related Software Problem	118
Partial Blockage	116
Sticking	104
Computer Software Problem	102
Motor	100
Failure To Deliver	99
Needle	93
Electrode	87
Moisture Damage	85
Electrical /Electronic Property Problem	84
Detachment Of Device Component	78
Leak / Splash	77
Improper Or Incorrect Procedure Or Method	76
Cap	73
Intermittent Communication Failure	71
Loss Of Power	70
Mechanical Jam	69
Loss Of Data	69
Inappropriate Or Unexpected Reset	65
Calibration Error	65
Application Interface Becomes Non-Functional Or Program Exits Abnormally	63
Component Falling	60
Scratched Material	59
Self-Activation Or Keying	59
Failure Of Device To Self-Test	54
Fracture	53
Material Twisted / Bent	53
Difficult To Remove	51
False Reading From Device Non-Compliance	51
Noise, Audible	51
Display	47
Poor Quality Image	46
Retraction Problem	46
Loose Or Intermittent Connection	45
Unintended Movement	40
Failure To Power Up	37
Unexpected Shutdown	36
Material Separation	35
Low Battery	34
Reset Problem	32
Transmitter	30
Activation Problem	30
Material Deformation	29
Battery	28
Device Stops Intermittently	27
Fitting Problem	27
Difficult To Insert	25
Total Device Problems	49902

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc.	II	Dec-22-2018
2	Medtronic Inc.	II	Feb-21-2018

TPLC Last Update: 2019-04-02 19:39:37