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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INT'L IQ200
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IRIS INT'L IQ200 Back to Search Results
Catalog Number 700-3375
Device Problems Increase in Pressure (1491); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2015
Event Type  malfunction  
Event Description
The customer stated the iq200 analyzer is blowing too much air into patient samples and causing the samples to overflow.There were no erroneous patient results generated or reported out of the lab.There were no changes to patient management.
 
Manufacturer Narrative
Iris field service engineer (fse) went to the customer site and found the air pressure is blowing the patient samples over the tops of the tubes.Fse adjusted the specimen provider assembly (spa), replaced the pipette p/n: 700-3711, adjusted the air pressure.Fse reran controls and the controls passed.The system was operational.(b)(4).
 
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Brand Name
IQ200
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 Key4921916
MDR Text Key6434858
Report Number2023446-2015-00186
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 01/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2015
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 Received01/14/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2011
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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