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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTL IQ200 AUTOMATED URINE MICROSCOPY
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IRIS INTL IQ200 AUTOMATED URINE MICROSCOPY Back to Search Results
Catalog Number 700-3322
Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954); Incorrect Device Or Component Shipped (2962)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2014
Event Type  No Answer Provided  
Event Description
Customer reported high concentration flags when running bf background on the iq200 unit.
 
Manufacturer Narrative
Iq200 automated urine microscopy analyzer reported to have high concentration flag while running bf controls which has the potential of affecting pt samples by producing a false low/false negative operating room false high/false positive cells (rbcs and wbcs) on body fluids and urine samples.Fse replaced flow cell and strobe light and performed manual focus, ran auto focus, controls, body fluid controls, and pt samples which all passed.Instrument was operational.
 
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Brand Name
IQ200 AUTOMATED URINE MICROSCOPY
Type of Device
IQ200
Manufacturer (Section D)
IRIS INTL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277497
MDR Report Key3698357
MDR Text Key4267900
Report Number2023446-2014-00023
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 01/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2014
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 Received01/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2009
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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