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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS DIAGNOSTICS ICHEM VELOCITY
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IRIS DIAGNOSTICS ICHEM VELOCITY Back to Search Results
Catalog Number 700-7177-001
Device Problems False Negative Result (1225); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2015
Event Type  malfunction  
Event Description
Customer stated they are failing ca control for bilirubin.
 
Manufacturer Narrative
Customer stated they are failing ca control for bilirubin.The customer is not aware of any erroneous results being generated or reported out of the lab.Iris field service engineer (fse), went to the customer site, and observed the syringe was loose causing air to get into the line.The fse tightened the syringe to resolve the issue.Fse reran controls and the controls passed.The system was operational.
 
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Brand Name
ICHEM VELOCITY
Manufacturer (Section D)
IRIS DIAGNOSTICS
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4798176
MDR Text Key5880876
Report Number2023446-2015-00162
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101852
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 04/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-7177-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2012
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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