Brand Name | XN-10 |
Type of Device | AUTOMATED HEMATOLOGY ANALYZER |
Manufacturer (Section D) |
SYSMEX CORPORATION, I SQUARE |
262-11 mizuashi |
noguchi-cho |
kakogawa-city, hyogo 675-0 019 |
JA 675-0019 |
|
Manufacturer (Section G) |
SYSMEX CORPORATION, I SQUARE |
262-11 mizuashi |
noguchi-cho |
kakogawa-city, hyogo 675-0 019 |
JA
675-0019
|
|
Manufacturer Contact |
peter
shearstone
|
577 aptakisic rd |
lincolnshire, IL 60069
|
2245439514
|
|
MDR Report Key | 7555161 |
MDR Text Key | 109613395 |
Report Number | 1000515253-2018-00007 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 04987562424214 |
UDI-Public | (01)04987562424214 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112605 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Medical Technologist
|
Type of Report
| Initial |
Report Date |
05/30/2018 |
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 |
Medical Technologist
|
Device Model Number | XN-10 |
Device Catalogue Number | AP795756 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/30/2018
|
Initial Date FDA Received | 05/30/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 03/11/2016 |
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 2 DA |
Patient Weight | 2 |
|
|