Brand Name | ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER |
Type of Device | ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
511 benedict ave |
tarrytown NY 10591 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
chapel lane, swords, co. |
registration number: 8020888 |
dublin, |
EI
|
|
Manufacturer Contact |
christina
lam
|
511 benedict ave |
tarrytown, NY 10591
|
9145243504
|
|
MDR Report Key | 8113151 |
MDR Text Key | 129254218 |
Report Number | 2432235-2018-00440 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 00630414560045 |
UDI-Public | 00630414560045 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K162977 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/28/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/28/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER |
Device Catalogue Number | 10285573 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/07/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/03/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |