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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 700-3322
Device Problems False Negative Result (1225); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2013
Event Type  malfunction  
Event Description
Customer reported samples auto release/auto file incorrectly.Most samples which were auto released/auto filed incorrectly were repeated manually and results corrected.
 
Manufacturer Narrative
Customer stated iq200 reported incorrect auto filing and auto release of pt samples.False negative results were reported and subsequently corrected however there were no reports of change to pt management as a result.Most samples which were auto released/auto filed incorrectly were repeated manually and results corrected.
 
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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
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277272
MDR Report Key4441544
MDR Text Key5311960
Report Number2023446-2015-00007
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 01/16/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-3322
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/16/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2011
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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