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 386 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 |
road 31 km 24.4 |
juncos PR 00777 386 |
|
Manufacturer Contact |
christopher
tupper
|
18000 devonshire street |
northridge, CA 91325-1219
|
8185764313
|
|
MDR Report Key | 4946291 |
MDR Text Key | 15387630 |
Report Number | 3004209178-2015-78208 |
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 |
07/20/2015 |
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-723NAS |
Device Catalogue Number | MMT-723NAS |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/20/2015 |
Initial Date FDA Received | 07/28/2015 |
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 | 58 YR |
Patient Weight | 91 |