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
|
8185464805
|
|
MDR Report Key | 10023852 |
MDR Text Key | 190886814 |
Report Number | 2032227-2020-113221 |
Device Sequence Number | 1 |
Product Code |
MDS
|
UDI-Device Identifier | 00763000215538 |
UDI-Public | (01)00763000215538(17)200630 |
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 |
|
Type of Report
| Initial,Followup |
Report Date |
05/13/2020 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 05/05/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 06/30/2020 |
Device Model Number | MMT-7811NA |
Device Catalogue Number | MMT-7811NA |
Device Lot Number | A000769495 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/07/2020 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 05/13/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/03/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|