Brand Name | SENSOR ENLITE MMT-7008A |
Type of Device | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 road |
juncos 00777 -386 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 road |
|
juncos 00777 -386 |
|
Manufacturer Contact |
gerwin
de graaff
|
ceiba norte ind. park #50 road |
juncos 00777--386
|
|
MDR Report Key | 7640918 |
MDR Text Key | 112420555 |
Report Number | 3004209178-2018-85559 |
Device Sequence Number | 1 |
Product Code |
OZO
|
UDI-Device Identifier | 20643169646432 |
UDI-Public | (01)20643169646432(017)20180430 |
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 |
Patient
|
Type of Report
| Initial,Followup |
Report Date |
11/18/2018 |
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 | 04/30/2018 |
Device Model Number | MMT-7008A |
Device Catalogue Number | MMT-7008A |
Device Lot Number | HG23Q0J |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/13/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/02/2018 |
Initial Date FDA Received | 06/27/2018 |
Supplement Dates Manufacturer Received | 11/14/2018
|
Supplement Dates FDA Received | 11/19/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
Patient Age | 52 YR |
Patient Weight | 255 |