Brand Name | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM |
Type of Device | COUNTER, DIFFERENTIAL CELL |
Manufacturer (Section D) |
BECKMAN COULTER |
250 s. kraemer blvd. |
brea CA 92821 |
|
Manufacturer (Section G) |
BECKMAN COULTER |
11800 sw 147th avenue |
|
miami FL 33196 2031 |
|
Manufacturer Contact |
laurie
o'riordan
|
11800 sw 147th avenue |
miami, FL 33196-2031
|
3053802874
|
|
MDR Report Key | 7726748 |
MDR Text Key | 115538093 |
Report Number | 1061932-2018-01005 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 15099590381646 |
UDI-Public | (01)15099590381646(11)NO-DATA |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K140811 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Repair |
Type of Report
| Initial,Followup |
Report Date |
08/28/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/27/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | TN,DXH 800 HEMATOLOGY SYSTEM |
Device Catalogue Number | 629029 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/30/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/01/2012 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | 2050012-0730/2018-011-C |
Patient Sequence Number | 1 |