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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INT'L ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER
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IRIS INT'L ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER Back to Search Results
Catalog Number 700-7177-001
Device Problems Device Operates Differently Than Expected (2913); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2015
Event Type  malfunction  
Event Description
The customer reported they are failing ca control for bilirubin.
 
Manufacturer Narrative
Customer reported the ichem velocity was failing ca control for bilirubin.There was no erroneous pt results generated or reported out of the lab.Itis field svc engineer evaluated the instrument and observed bubbles in the sample line during the initial prime.The fse replaced the syringe pump assembly and the rinse pump.The fse ran controls which passed and system was operational.
 
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Brand Name
ICHEM VELOCITY
Type of Device
AUTOMATED URINE CHEMISTRY ANALYZER
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 Key4824073
MDR Text Key5836924
Report Number2023446-2015-00171
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 05/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2015
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 Received05/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
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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