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 |
* 00777-3869 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 road |
|
juncos 00777 -386 |
*
00777-3869
|
|
Manufacturer Contact |
tricha
miles
|
ceiba norte ind. park #50 road |
juncos 00777--386
|
*
00777-3869
|
7635140379
|
|
MDR Report Key | 12195834 |
MDR Text Key | 264817346 |
Report Number | 2032227-2021-170013 |
Device Sequence Number | 1 |
Product Code |
OZO
|
UDI-Device Identifier | 000020643169786725 |
UDI-Public | (01)000020643169786725(17)211005(10)HG56YZB |
Combination Product (y/n) | N |
Reporter Country Code | CH |
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 |
07/20/2021 |
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 | 10/05/2021 |
Device Model Number | MMT-7008A |
Device Catalogue Number | MMT-7008A |
Device Lot Number | HG56YZB |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/10/2021 |
Initial Date FDA Received | 07/20/2021 |
Date Device Manufactured | 04/08/2021 |
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 |