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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS DIAGNOSTICS IQ200; AUTOMATED URINE MICROSCOPY ANALYZER
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IRIS DIAGNOSTICS IQ200; AUTOMATED URINE MICROSCOPY ANALYZER Back to Search Results
Catalog Number 700-3347
Device Problems Charred (1086); Device Emits Odor (1425); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2014
Event Type  malfunction  
Event Description
Customer reported a burning smell from the unit.
 
Manufacturer Narrative
A burning smell was reported from the iq 200.Iris field service engineer (fse) inspected instrument and found backplane at stm ssmb board/power sic chip was burned.The instrument will be replaced due to resulting damage from failed pcb boards.Fire department was not called and no reports of injuries or medical interventions were made.
 
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Brand Name
IQ200
Type of Device
AUTOMATED URINE MICROSCOPY ANALYZER
Manufacturer (Section D)
IRIS DIAGNOSTICS
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277272
MDR Report Key4254616
MDR Text Key5044961
Report Number2023446-2014-00177
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 10/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-3347
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2014
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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