Brand Name | COULTER LH 500 HEMATOLOGY ANALYZER |
Type of Device | COUNTER, DIFFERENTIAL CELL |
Manufacturer (Section D) |
BECKMAN COULTER |
250 south kraemer blvd. |
brea CA 92821 |
|
Manufacturer (Section G) |
BECKMAN COULTER |
11800 sw 147th ave |
|
miami FL 33196 |
|
Manufacturer Contact |
miranda
holland
|
11800 sw 147th ave |
32-s08 |
miami, FL 33196
|
3053802031
|
|
MDR Report Key | 5328380 |
MDR Text Key | 34384513 |
Report Number | 1061932-2015-01875 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K042724 |
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 |
11/25/2015 |
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 |
Health Professional
|
Device Catalogue Number | 178833 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/25/2015
|
Initial Date FDA Received | 12/26/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/2009 |
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 |