Brand Name | COBAS 8000 E 602 MODULE |
Type of Device | IMMUNOCHEMISTRY ANALYZER |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
HITACHI HIGH TECH CORP. |
882 ichige hitachinaka |
na |
ibaraki 312-8 504 |
JA
312-8504
|
|
Manufacturer Contact |
michael
leslie
|
9115 hague road |
na |
indianapolis, IN 46250
|
3175214343
|
|
MDR Report Key | 6979832 |
MDR Text Key | 91097134 |
Report Number | 1823260-2017-02426 |
Device Sequence Number | 0 |
Product Code |
JMG
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K100853 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/16/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | E602 |
Device Catalogue Number | ASKU |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/05/2017
|
Initial Date FDA Received | 10/26/2017 |
Supplement Dates Manufacturer Received | 10/05/2017
|
Supplement Dates FDA Received | 11/16/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 43 YR |
|
|