Brand Name | XMTR MMT-7811NA GST3C LOCKOUT |
Type of Device | SENSOR, GLUCOSE, INVASIVE |
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
|
|
MDR Report Key | 7400202 |
MDR Text Key | 104525236 |
Report Number | 2032227-2018-02351 |
Device Sequence Number | 1 |
Product Code |
MDS
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial,Followup |
Report Date |
04/16/2020 |
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 Model Number | MMT-7811NA |
Device Catalogue Number | MMT-7811NA |
Device Lot Number | A000389095 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/04/2018 |
Initial Date FDA Received | 04/05/2018 |
Supplement Dates Manufacturer Received | 04/16/2020
|
Supplement Dates FDA Received | 04/16/2020
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 Outcome(s) |
Hospitalization;
|
Patient Age | 56 YR |
Patient Weight | 175 |
|
|