Brand Name | SENSOR ENLITE MMT-7008B |
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 | 8295123 |
MDR Text Key | 134691345 |
Report Number | 2032227-2019-01072 |
Device Sequence Number | 1 |
Product Code |
OZO
|
UDI-Device Identifier | 00643169541719 |
UDI-Public | (01)00643169541719(17)190426(10)J288P |
Combination Product (y/n) | N |
Reporter Country Code | GM |
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 |
01/31/2019 |
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 | 04/26/2019 |
Device Model Number | MMT-7008B |
Device Catalogue Number | MMT-7008B |
Device Lot Number | J288P |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
01/21/2019 |
Initial Date FDA Received | 01/31/2019 |
Date Device Manufactured | 10/28/2018 |
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 |
Patient Outcome(s) |
Other;
|