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 |
|
Manufacturer (Section G) |
MEDTRONIC MINIMED |
18000 devonshire st. |
|
northridge CA 91325 |
|
Manufacturer Contact |
tricha
miles
|
18000 devonshire st. |
northridge, CA 91325
|
7635140379
|
|
MDR Report Key | 13123236 |
MDR Text Key | 283151100 |
Report Number | 2032227-2021-237107 |
Device Sequence Number | 1 |
Product Code |
OYC
|
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 |
Other
|
Type of Report
| Initial |
Report Date |
12/30/2021 |
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 |
12/29/2021 |
Initial Date FDA Received | 12/30/2021 |
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-MMT-332-RSVR, UNOMED SET. |
Patient Outcome(s) |
Other;
|