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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 700-3320
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Application Program Version or Upgrade Problem (2881); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2013
Event Type  malfunction  
Event Description
An isolated incident of a dilution error was reported by the customer.Customer stated that they did a dilution and the dilution multiplied by 10,000 instead of normal dilution value.
 
Manufacturer Narrative
Iq200 automated urine microscopy analyzer software version reporting a higher dilution ratio than normally given for urine samples, especially bloody and turbid samples.There is no evidence of a systemic failure in the instrument or known defects which would cause the reported issue.This is an isolated incident.
 
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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 Key3750496
MDR Text Key15931858
Report Number2023446-2014-00006
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 11/03/2013
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 Number700-3320
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2013
Initial Date FDA Received01/31/2014
Was Device Evaluated by Manufacturer? Yes
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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