Brand Name | IQ200 URINE ANALYZER |
Type of Device | AUTOMATED URINALYSIS SYSTEM |
Manufacturer (Section D) |
BECKMAN COULTER IRELAND INC. |
lismeehan |
o¿callaghan¿s mills |
country clare |
EI |
|
Manufacturer (Section G) |
BECKMAN COULTER |
1000 lake hazeltine drive |
|
chaska MN 55318 |
|
Manufacturer Contact |
angela
vettel
|
250 kraemer blvd |
brea, CA 92821
|
7149613625
|
|
MDR Report Key | 14026109 |
MDR Text Key | 289008325 |
Report Number | 2122870-2022-00018 |
Device Sequence Number | 1 |
Product Code |
KQO
|
UDI-Device Identifier | 10837461001256 |
UDI-Public | (01)10837461001256(11)NO-DATA |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K022774 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/06/2022 |
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 |
Health Professional
|
Device Model Number | IQ200 SPRINT 2008 TESTED |
Device Catalogue Number | 700-3325 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/18/2022
|
Initial Date FDA Received | 04/06/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Other;
|