FDA Adverse Event
Malfunction
Summary report: N
IQ 200 SYSTEM
MDR report key: 6074863
·
Received November 2, 2016
Report
- Report Number
- 2023446-2016-00392
- Event Type
- Malfunction
- Date Received
- November 2, 2016
- Date of Event
- October 8, 2016
- Report Date
- October 8, 2016
- Manufacturer
- IRIS INTERNATIONAL
- Product Code
- KQO
- UDI-DI
- 10837461001324
- PMA / PMN Number
- K022774
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADVERSE EVENT OR PRODUCT PROBLEM: INADVERTENTLY OMITTED FROM ORIGINAL SUBMISSION.
Additional Manufacturer Narrative · 1
THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND OBSERVED THAT THE SOURCE OF THE PROBLEM WAS THE EVACUATION BYPASS VALVE (EBV). HE REPLACED THE EBV TO RESOLVE THE REPORTED ISSUE. THE REPAIRS WERE VERIFIED AS PER SERVICE PROCEDURES. BEC INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(6).
Description of Event or Problem · 1
THE CUSTOMER REPORTED BODILY FLUID CONTROL FAILURE AND RBC WAS FAILING LOW ON THEIR IQ 200 SYSTEM. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED. THERE WAS NO CHANGE TO PATIENT TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723653 | IQ 200 SYSTEM | AUTOMATED URINALYSIS SYSTEM | KQO | IRIS INTERNATIONAL | NA | 10837461001324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |