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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200 AUTOMATED URINE MICROSCOPY
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IRIS INTERNATIONAL IQ200 AUTOMATED URINE MICROSCOPY Back to Search Results
Catalog Number 700-3375
Device Problems Low Test Results (2458); Device Operates Differently Than Expected (2913); Optical Distortion (3000)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2013
Event Type  malfunction  
Event Description
Customer reported getting low rbc counts and blurry cells with body fluids.
 
Manufacturer Narrative
Iq200 urine microscopy body fluid module reporting false low/false negative rbc count and cells are blurry (focus failure).Fse replaced pbv, tubing, pipette and pump cassettes.Fse also discussed system performance with the operator and performed system calibration.System was operational.
 
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Brand Name
IQ200 AUTOMATED URINE MICROSCOPY
Type of Device
IQ200
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277497
MDR Report Key3750492
MDR Text Key16802241
Report Number2023446-2014-00009
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 04/30/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-3375
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/30/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2011
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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