Brand Name | INSTRUMENT GENERATED TWO DIFFERENT CHEMISTRY SYSTEM FLAG MESSAGES (CHEMTRANSLATE |
Type of Device | AUTOMATED URINALYSIS SYSTEM, |
Manufacturer (Section D) |
IRIS INTERNATIONAL |
9172 eton ave |
chatsworth CA 91311 |
|
Manufacturer (Section G) |
IRIS INTERNATIONAL |
9172 eton ave |
|
chatsworth CA 91311 |
|
Manufacturer Contact |
laurie
o'riordan
|
9172 eton ave |
chatsworth, CA 91311
|
3053802874
|
|
MDR Report Key | 7077115 |
MDR Text Key | 93552647 |
Report Number | 2023446-2017-00010 |
Device Sequence Number | 1 |
Product Code |
KQO
|
UDI-Device Identifier | 10837461001737 |
UDI-Public | (01)10837461001737(11)NO-DATA |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101852 |
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 |
11/03/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/01/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other Health Care Professional
|
Device Catalogue Number | 700-7176-001 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/03/2017 |
Date Device Manufactured | 03/06/2014 |
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;
|
Patient Age | 79 YR |