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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER
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IRIS INTERNATIONAL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER Back to Search Results
Catalog Number 700-3370
Device Problems Fluid/Blood Leak (1250); Low Test Results (2458); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2015
Event Type  malfunction  
Event Description
The customer stated they had a leak coming from the inside the instrument near the probe.
 
Manufacturer Narrative
The customer stated the instrument is leaking near the probe.There were no erroneous patient results generated or reported.There was no exposure and no injuries associated with the leak.Iris field service engineer was sent to the customer location and replaced the rinse well, ebv valve and filter.This resolved the leak.The fse ran controls and the controls passed, the system was operational.
 
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Brand Name
IQ200
Type of Device
AUTOMATED URINE MICROSCOPY ANALYZER
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4763499
MDR Text Key5949043
Report Number2023446-2015-00149
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-3370
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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