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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 700-3345
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 03/03/2015
Event Type  malfunction  
Event Description
Customer reports instrument is inconsistent with short sample detection error.
 
Manufacturer Narrative
The customer reported their instrument is inconsistent with short sample detection.Iris field service engineer was sent to the customer location and verified tubes run with no sample are not being detected flagged and reads as a negative test result.This issue is currently under investigation.There is no indication erroneous pt results were generated or reported out of the lab.There is no reported change to pt treatment.
 
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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
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4645123
MDR Text Key5602028
Report Number2023446-2015-00077
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K022774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2015
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 Number700-3345
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/03/2015
Initial Date FDA Received03/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
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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