Brand Name | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP |
Type of Device | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 road |
juncos 00777 -386 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 road |
|
juncos 00777 -386 |
|
Manufacturer Contact |
gerwin
de graaff
|
ceiba norte ind. park #50 road |
juncos 00777--386
|
8185464805
|
|
MDR Report Key | 10912742 |
MDR Text Key | 218510041 |
Report Number | 2032227-2020-210785 |
Device Sequence Number | 1 |
Product Code |
OYC
|
UDI-Device Identifier | 000000643169513136 |
UDI-Public | (01)000000643169513136 |
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,Followup |
Report Date |
02/01/2021 |
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-723RNAP |
Device Catalogue Number | MMT-723RNAP |
Device Lot Number | A1723RNAPJ |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/21/2021 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/21/2020 |
Initial Date FDA Received | 11/26/2020 |
Supplement Dates Manufacturer Received | 01/29/2021
|
Supplement Dates FDA Received | 02/01/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/22/2016 |
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 | 74 YR |