| Device Type ID | 2669 |
| Device Name | Pump, Infusion, Insulin |
| Regulation Description | Infusion Pump. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LZG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2669 |
| Device | Pump, Infusion, Insulin |
| Product Code | LZG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ASANTE SOLUTIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSULET CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
INSULET CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
TANDEM DIABETES CARE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
| Device Problems | |
|---|---|
Pumping Stopped | 17270 |
Device Displays Incorrect Message | 13977 |
Adverse Event Without Identified Device Or Use Problem | 13252 |
Cannula | 10857 |
Device Operates Differently Than Expected | 10509 |
Mechanical Problem | 9276 |
Incorrect Measurement | 9132 |
Occlusion Within Device | 8488 |
Unintended Movement | 7960 |
Tube | 7310 |
Bent | 5724 |
Insufficient Information | 5721 |
Failure To Prime | 5010 |
Charging Problem | 4874 |
Crack | 4825 |
Filling Problem | 3951 |
Poor Quality Image | 3660 |
Break | 3416 |
No Display / Image | 3396 |
False Alarm | 3265 |
Structural Problem | 3262 |
Display | 3232 |
Inaccurate Delivery | 3095 |
Material Twisted / Bent | 2824 |
Use Of Device Problem | 2777 |
Battery Problem | 2649 |
Fail-Safe Problem | 2504 |
Image Display Error / Artifact | 2259 |
Needle | 2119 |
Visual Prompts Will Not Clear | 2119 |
Moisture Damage | 2091 |
Failure To Adhere Or Bond | 1981 |
Leak / Splash | 1854 |
Device Inoperable | 1625 |
Failure To Sense | 1615 |
Kinked | 1583 |
Switch, Push Button | 1574 |
Partial Blockage | 1568 |
Obstruction Of Flow | 1504 |
Activation, Positioning Or Separation Problem | 1418 |
Housing | 1374 |
Inappropriate Or Unexpected Reset | 1283 |
Device Issue | 1138 |
Keypad | 1110 |
Difficult To Insert | 1071 |
Connection Problem | 1045 |
Battery | 1010 |
Positioning Failure | 999 |
Device Alarm System | 935 |
Electrical /Electronic Property Problem | 885 |
Pump | 812 |
Date/Time-Related Software Problem | 722 |
Fluid Leak | 693 |
Device Difficult To Program Or Calibrate | 690 |
Insufficient Flow Or Under Infusion | 668 |
Data Problem | 635 |
Premature Discharge Of Battery | 616 |
Device Sensing Problem | 594 |
Screen | 592 |
Loss Of Or Failure To Bond | 579 |
Loose Or Intermittent Connection | 573 |
Difficult Or Delayed Activation | 540 |
Fitting Problem | 527 |
Cover | 506 |
Detachment Of Device Component | 501 |
Failure To Read Input Signal | 493 |
Inadequate User Interface | 482 |
Physical Resistance | 474 |
Moisture Or Humidity Problem | 437 |
Cap | 434 |
Device Stops Intermittently | 410 |
Loss Of Power | 388 |
Temperature Problem | 377 |
Retraction Problem | 347 |
Failure To Power Up | 320 |
Power Problem | 318 |
Defective Alarm | 262 |
Improper Or Incorrect Procedure Or Method | 252 |
Material Discolored | 245 |
Device Subassembly | 241 |
Pumping Problem | 239 |
Detachment Of Device Or Device Component | 230 |
Failure To Cycle | 225 |
Infusion Or Flow Problem | 215 |
Scratched Material | 215 |
Out-Of-Box Failure | 208 |
Fail-Safe Did Not Operate | 202 |
Display Or Visual Feedback Problem | 196 |
Disconnection | 194 |
Wireless Communication Problem | 185 |
Excess Flow Or Over-Infusion | 174 |
Corroded | 162 |
Appropriate Term/Code Not Available | 137 |
Communication Or Transmission Problem | 134 |
Display Difficult To Read | 115 |
Vibration | 115 |
Use Of Incorrect Control Settings | 114 |
Alarm | 111 |
Improper Flow Or Infusion | 111 |
Patient Device Interaction Problem | 107 |
| Total Device Problems | 224493 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Animas Corporation | II | Oct-24-2014 |
| 2 | Elcam Medical, Inc. | II | Sep-10-2015 |
| 3 | Insulet Corporation | I | Dec-15-2015 |
| 4 | Insulet Corporation | I | Sep-04-2015 |
| 5 | Medtronic MiniMed | III | Jun-25-2015 |
| 6 | Medtronic MiniMed Inc. | III | Mar-02-2015 |
| 7 | Roche Diabetes Care, Inc. | II | Jun-09-2015 |
| 8 | Roche Diagnostics Operations, Inc. | II | Oct-29-2014 |
| 9 | Tandem Diabetes Care Inc | I | Feb-10-2014 |