Brand Name | LX AQUA CALIBRATOR LEVEL 1 |
Type of Device | LX AQUA CALIBRATOR LEVEL 1 |
Manufacturer (Section D) |
BECKMAN COULTER |
2470 faraday ave |
carlsbad CA 92010 |
|
Manufacturer (Section G) |
BECKMAN COULTER |
2470 faraday ave |
|
carlsbad CA 92010 |
|
Manufacturer Contact |
david
davis
|
250 s. kraemer blvd. |
m/s e1.se.01 |
brea, CA 92821
|
7149313796
|
|
MDR Report Key | 7222202 |
MDR Text Key | 98527473 |
Report Number | 2050010-2018-00001 |
Device Sequence Number | 1 |
Product Code |
JIX
|
UDI-Device Identifier | 15099590233402 |
UDI-Public | (01)15099590233402(17)181130(11)NO-DATA(10)72853811 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071277 |
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
|
Type of Report
| Initial |
Report Date |
01/02/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/26/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/20/2018 |
Device Catalogue Number | 471288 |
Device Lot Number | 72853811 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/02/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/17/2017 |
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 |