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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER
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IRIS INTERNATIONAL ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER 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 03/08/2015
Event Type  malfunction  
Event Description
Customer reported control is failing for bilirubin.
 
Manufacturer Narrative
Customer reported the ichem velocity failing ca control for bilirubin.There were no reports of patient results being affected and no reports of patient results being affected and no reports of change to patient mgmt as a result.An iris field service engineer (fse) adjusted the probe alignment.The fse ran qc which passed.System was operational.
 
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Brand Name
ICHEM VELOCITY
Type of Device
AUTOMATED URINE CHEMISTRY 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 Key4671132
MDR Text Key5734023
Report Number2023446-2015-00103
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 03/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2015
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 Received03/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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