Brand Name | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAB |
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 | 7655598 |
MDR Text Key | 112919872 |
Report Number | 3004209178-2018-86863 |
Device Sequence Number | 1 |
Product Code |
OYC
|
UDI-Device Identifier | 00643169513822 |
UDI-Public | (01)00643169513822 |
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 |
08/27/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/02/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | MMT-523LNAB |
Device Catalogue Number | MMT-523LNAB |
Device Lot Number | A4523LNABJ |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/02/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/06/2016 |
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 Outcome(s) |
Other;
|
Patient Age | 69 YR |
Patient Weight | 136 |