Brand Name | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS |
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 |
tricha
miles
|
18000 devonshire st. |
northridge, CA 91325-1219
|
7635140379
|
|
MDR Report Key | 12039564 |
MDR Text Key | 257403202 |
Report Number | 2032227-2021-159685 |
Device Sequence Number | 1 |
Product Code |
OYC
|
UDI-Device Identifier | 000000763000161132 |
UDI-Public | (01)000000763000161132 |
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 |
06/22/2021 |
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-723LNAS |
Device Catalogue Number | MMT-723LNAS |
Device Lot Number | A7723LNASJ |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/17/2021 |
Initial Date FDA Received | 06/22/2021 |
Date Device Manufactured | 01/31/2020 |
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-MMT-332-RSVR, UNOMED SET |
Patient Outcome(s) |
Other;
|
Patient Age | 62 YR |
Patient Weight | 63 |