Brand Name | 630G INSULIN PUMP MMT-1715KL 630G |
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 |
gerwin
de graaff
|
ceiba norte ind. park #50 road |
juncos 00777--386
|
*
00777-3869
|
8185464805
|
|
MDR Report Key | 11129943 |
MDR Text Key | 225473843 |
Report Number | 2032227-2021-101684 |
Device Sequence Number | 1 |
Product Code |
OZO
|
UDI-Device Identifier | 000000763000166519 |
UDI-Public | (01)000000763000166519(17)220711 |
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 |
Other
|
Type of Report
| Initial |
Report Date |
01/07/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/07/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 07/11/2022 |
Device Model Number | MMT-1715KL |
Device Catalogue Number | MMT-1715KL |
Device Lot Number | HG3L1D1 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 01/04/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/12/2019 |
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 |
Treatment | FRN-UNK-RSVR, UNOMED SET, OZP-MMT-7020-SNSR |
Patient Outcome(s) |
Other;
|
Patient Age | 39 YR |
Patient Weight | 66 |