Brand Name | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP |
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
|
8185464805
|
|
MDR Report Key | 11025526 |
MDR Text Key | 221995417 |
Report Number | 2032227-2020-218321 |
Device Sequence Number | 1 |
Product Code |
OYC
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Type of Report
| Initial |
Report Date |
12/16/2020 |
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-XXX |
Device Catalogue Number | MMT-XXX |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/13/2020 |
Initial Date FDA Received | 12/17/2020 |
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. |
Patient Outcome(s) |
Hospitalization;
|