Brand Name | SENSOR ENLITE MMT-7008A |
Type of Device | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND |
Manufacturer (Section D) |
MEDTRONIC MINIMED |
18000 devonshire st. |
northridge CA 91325 1219 |
|
Manufacturer (Section G) |
MEDTRONIC MINIMED |
18000 devonshire st. |
|
northridge CA 91325 1219 |
|
Manufacturer Contact |
gerwin
de graaff
|
18000 devonshire st. |
northridge, CA 91325-1219
|
8185464805
|
|
MDR Report Key | 10618672 |
MDR Text Key | 209536378 |
Report Number | 2032227-2020-185503 |
Device Sequence Number | 1 |
Product Code |
OZO
|
UDI-Device Identifier | 000020643169541706 |
UDI-Public | (01)000020643169541706(17)201004(10)D070P |
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/02/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 10/04/2020 |
Device Model Number | MMT-7008A |
Device Catalogue Number | MMT-7008A |
Device Lot Number | D070P |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/22/2020 |
Initial Date FDA Received | 10/02/2020 |
Date Device Manufactured | 04/07/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |