Brand Name | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH |
Type of Device | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
Manufacturer (Section D) |
MEDTRONIC MINIMED |
18000 devonshire st. |
northridge CA 91325 1219 |
|
Manufacturer (Section G) |
MEDTRONIC MINIMED |
18000 devonshire st. |
|
northridge CA 91325 1219 |
|
Manufacturer Contact |
gerwin
de graaff
|
18000 devonshire st. |
northridge, CA 91325-1219
|
|
MDR Report Key | 7390400 |
MDR Text Key | 104225545 |
Report Number | 2032227-2018-02293 |
Device Sequence Number | 1 |
Product Code |
OYC
|
UDI-Device Identifier | 00643169221529 |
UDI-Public | (01)00643169221529 |
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 |
Patient
|
Type of Report
| Initial,Followup |
Report Date |
09/06/2018 |
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 Model Number | MMT-523RNAH |
Device Catalogue Number | MMT-523RNAH |
Device Lot Number | A000291727 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/27/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/13/2018
|
Initial Date FDA Received | 04/02/2018 |
Supplement Dates Manufacturer Received | 08/11/2018
|
Supplement Dates FDA Received | 09/06/2018
|
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 Age | 71 YR |
Patient Weight | 209 |