Definition: The Insulin Pump Is Intended To Be Used As A Component Of An Invasive Glucose Device. The Pump Is Designed To Pump Fluid (insulin) Into A Patient In A Controlled Manner As An Aid In The Mangement Of Diabetes Mellitus In Persons Requiring Insulin. It
| Device Type ID | 712 |
| Device Name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Physical State | Must Include Product Code MDS, Sensor, Invasive Test System, Or Product Code PQF, Sensor, Glucose, Invasive, Non-adjunctive. |
| Technical Method | The Pump Is Designed To Pump Fluid (insulin) Into A Patient In A Controlled Manner As An Aid In The Mangement Of Diabetes Mellitus In Persons Requiring Insulin. It Is Intended To Accept And Display Data From The Glucose Sensor |
| Target Area | See Indications For Use |
| 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 | OYC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 712 |
| Device | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Product Code | OYC |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 27482 |
Structural Problem | 21414 |
Patient Device Interaction Problem | 12707 |
Pumping Stopped | 9837 |
Wireless Communication Problem | 8759 |
Adverse Event Without Identified Device Or Use Problem | 8623 |
Image Display Error / Artifact | 8472 |
No Display / Image | 6505 |
Device Alarm System | 6214 |
Incorrect Measurement | 5918 |
Device Operates Differently Than Expected | 5758 |
Mechanical Problem | 5751 |
Moisture Damage | 4783 |
Appropriate Term/Code Not Available | 4331 |
Fail-Safe Problem | 4189 |
Obstruction Of Flow | 4060 |
Power Problem | 4036 |
Switch, Push Button | 3942 |
Electrical /Electronic Property Problem | 3930 |
Charging Problem | 3792 |
Battery Problem | 3529 |
Device Inoperable | 3203 |
Device Difficult To Program Or Calibrate | 2877 |
Failure To Read Input Signal | 2714 |
No Apparent Adverse Event | 2669 |
Occlusion Within Device | 2255 |
Premature Discharge Of Battery | 2245 |
Imprecision | 2229 |
Keypad | 2225 |
Crack | 2202 |
Use Of Device Problem | 2116 |
Circuit Failure | 2084 |
Filling Problem | 1882 |
Failure To Prime | 1608 |
Communication Or Transmission Problem | 1458 |
Connection Problem | 1410 |
Failure To Cycle | 1370 |
Failure To Sense | 1341 |
Visual Prompts Will Not Clear | 1339 |
Display Or Visual Feedback Problem | 1317 |
False Alarm | 1108 |
Moisture Or Humidity Problem | 1090 |
Partial Blockage | 1033 |
Detachment Of Device Or Device Component | 956 |
Motor | 844 |
Cap | 754 |
Break | 752 |
Device Sensing Problem | 721 |
Priming Problem | 707 |
Invalid Sensing | 699 |
Insufficient Flow Or Under Infusion | 691 |
Date/Time-Related Software Problem | 623 |
Screen | 580 |
Computer Software Problem | 579 |
Device Issue | 576 |
Temperature Problem | 553 |
Defective Alarm | 507 |
Failure To Deliver | 507 |
Leak / Splash | 496 |
Human-Device Interface Problem | 494 |
Loose Or Intermittent Connection | 452 |
Self-Activation Or Keying | 442 |
Inaccurate Delivery | 431 |
Inappropriate Or Unexpected Reset | 427 |
Insufficient Information | 396 |
Detachment Of Device Component | 396 |
Sticking | 396 |
Improper Or Incorrect Procedure Or Method | 391 |
Excess Flow Or Over-Infusion | 388 |
Material Integrity Problem | 366 |
Physical Resistance / Sticking | 331 |
Material Protrusion / Extrusion | 328 |
Component Missing | 311 |
Data Problem | 310 |
Retraction Problem | 308 |
Physical Resistance | 267 |
Display | 260 |
Fitting Problem | 258 |
Component Falling | 256 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 255 |
Loss Of Power | 249 |
Scratched Material | 248 |
Poor Quality Image | 234 |
Housing | 232 |
Fluid Leak | 230 |
Improper Flow Or Infusion | 215 |
Loss Of Data | 214 |
Sensor | 200 |
Reset Problem | 192 |
Battery | 192 |
Failure To Power Up | 170 |
Unintended Movement | 163 |
Pumping Problem | 162 |
Failure Of Device To Self-Test | 160 |
Noise, Audible | 155 |
Device Stops Intermittently | 155 |
Reservoir | 148 |
No Audible Alarm | 148 |
Out-Of-Box Failure | 145 |
Transmitter | 143 |
| Total Device Problems | 227570 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Animas Corporation | II | Jan-30-2015 |
| 2 | Medtronic MiniMed Inc. | II | Dec-17-2015 |
| 3 | Medtronic MiniMed Inc. | II | Aug-22-2014 |
| 4 | Tandem Diabetes Care Inc | II | Jul-18-2018 |