Brand Name | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP |
Type of Device | INSULIN INFUSION PUMP / SENSOR AUGMENTED |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 |
road 31 km 24.4 |
juncos PR 00777 3869 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 |
road 31 km 24.4 |
juncos PR 00777 3869 |
|
Manufacturer Contact |
gerwin
de graaff
|
18000 devonshire street |
northridge, CA 91325-1219
|
8185764805
|
|
MDR Report Key | 6264102 |
MDR Text Key | 65300930 |
Report Number | 3004209178-2017-84934 |
Device Sequence Number | 1 |
Product Code |
OYC
|
Combination Product (y/n) | N |
PMA/PMN Number | P980022 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
01/14/2017 |
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 Model Number | MMT-723NAP |
Device Catalogue Number | MMT-723NAP |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/14/2017
|
Initial Date FDA Received | 01/19/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 30 YR |
Patient Weight | 63 |