Brand Name | XMTR MMT-7811NA GST3C LOCKOUT |
Type of Device | SENSOR, GLUCOSE, INVASIVE |
Manufacturer (Section D) |
MEDTRONIC MINIMED |
18000 devonshire st. |
northridge CA 91325 |
|
Manufacturer (Section G) |
MEDTRONIC MINIMED |
18000 devonshire st. |
|
northridge CA 91325 |
|
Manufacturer Contact |
tricha
miles
|
18000 devonshire st. |
northridge, CA 91325
|
7635140379
|
|
MDR Report Key | 13781885 |
MDR Text Key | 288034657 |
Report Number | 2032227-2022-141389 |
Device Sequence Number | 1 |
Product Code |
MDS
|
UDI-Device Identifier | 000000763000215538 |
UDI-Public | (01)000000763000215538(17)190804 |
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
03/15/2022 |
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 | 08/04/2019 |
Device Model Number | MMT-7811NA |
Device Catalogue Number | MMT-7811NA |
Device Lot Number | A000604660 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/10/2021 |
Initial Date FDA Received | 03/16/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/05/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 68 YR |
Patient Weight | 205 |