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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); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2015
Event Type  malfunction  
Manufacturer Narrative
Iris field service engineer was sent to the customer location.The fse found air in the fluidics from the syringe pump through to the color clarity and specific gravity module (cgm).The fse replaced the rinse pump assembly p/n: 700-7513 to resolve the control failure.The fse reran the controls and the controls passed.The system was operational.(b)(4).
 
Event Description
The customer reported failing ca quality controls for bilirubin.The customer was getting a false negative result and tried using fresh controls, but stilled failed.There were no erroneous results generated or reported out of the lab.
 
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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 avenue
chatsworth, CA 91311
8185277379
MDR Report Key5215477
MDR Text Key30979368
Report Number2023446-2015-00267
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 faci
Reporter Occupation Health Professional
Type of Report Initial
Report Date 10/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2015
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 Received10/27/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2013
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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