Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INT'L IQ200; AUTOMATED URINE MICROSCOPY ANALYZER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IRIS INT'L IQ200; AUTOMATED URINE MICROSCOPY ANALYZER Back to Search Results
Catalog Number 700-3321
Device Problems Device Operates Differently Than Expected (2913); Inadequate Lighting (2957)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2013
Event Type  malfunction  
Event Description
The customer stated short sample detection error was not generated on short pt samples.
 
Manufacturer Narrative
Distributor received a customer complaint for the velocity instrument; the customer stated when a low volume pt sample was run on the instrument there was no short sample detection error alarm.Iris tech applications specialist instructed distributor to upgrade the customer software to resolve the issue.The new version of the software detects short samples and displays an alarm on the customer instrument.There were no reports of pt results affected.There are no reports to changes in pt management.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IQ200
Type of Device
AUTOMATED URINE MICROSCOPY ANALYZER
Manufacturer (Section D)
IRIS INT'L
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4748986
MDR Text Key5770390
Report Number2023446-2015-00139
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K022774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/13/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-3321
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2013
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-