Brand Name | 630G INSULIN PUMP MMT-1715K 630G BLACK MG |
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 | 7647799 |
MDR Text Key | 112845095 |
Report Number | 3004209178-2018-86228 |
Device Sequence Number | 0 |
Product Code |
OZO
|
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 |
09/11/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/28/2018 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 06/23/2018 |
Device Model Number | MMT-1715K |
Device Catalogue Number | MMT-1715K |
Device Lot Number | HG27RRW |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/02/2018 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/15/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/20/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 0 |
Patient Age | 66 YR |
Patient Weight | 123 |