Brand Name | OMNIPOD DASH INSULIN MANAGEMENT SYSTEM |
Type of Device | PUMP, INFUSION, INSULIN |
Manufacturer (Section D) |
INSULET CORPORATION |
100 nagog park |
acton MA 01720 |
|
Manufacturer (Section G) |
INSULET CORPORATION |
100 nagog park |
|
acton MA 01720 |
|
Manufacturer Contact |
jordan
biswurm
|
100 nagog park |
acton, MA 01720
|
9786007000
|
|
MDR Report Key | 10756467 |
MDR Text Key | 213708857 |
Report Number | 3004464228-2020-17073 |
Device Sequence Number | 1 |
Product Code |
LZG
|
UDI-Device Identifier | 20385082000020 |
UDI-Public | (01)20385082000020(11)200430(17)211030(10)PD1C04302051 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K192659 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/16/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 10/30/2021 |
Device Model Number | 18320 |
Device Catalogue Number | BLE-I1-529 |
Device Lot Number | PD1C04302051 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/16/2020 |
Initial Date FDA Received | 10/29/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/30/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 48 YR |