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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER
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IRIS INTL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER Back to Search Results
Catalog Number 700-3322
Device Problems Low Test Results (2458); Device Operates Differently Than Expected (2913); Issue With Displayed Error Message (2967)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/12/2015
Event Type  malfunction  
Manufacturer Narrative
Customer reported false low cells (rbcs and wbcs) for 3 pt samples on iq200.After a re-run, the two results correlated.The qc passed.The results were not reported out of the lab and there were no reports of change to pt management.Customer was instructed (by phone) to change sample filter and run iq200 cleansers five times.Customer confirmed that changing the sample filter and running the clean racks resolved the issue.
 
Event Description
Customer reported getting negative results on positive samples.
 
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Brand Name
IQ200
Type of Device
AUTOMATED URINE MICROSCOPY ANALYZER
Manufacturer (Section D)
IRIS INTL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277272
MDR Report Key4483445
MDR Text Key16592341
Report Number2023446-2015-00011
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 01/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 01/12/2015
Initial Date FDA Received01/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2008
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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