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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 Tube (525); Fluid Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2015
Event Type  Malfunction  
Event Description

The customer stated there is a contained leak coming from tubing located between the probe and the color, clarity and specific gravity module (cgm).

 
Manufacturer Narrative

Customer reported the ichem velocity had a leak coming from the cgm tubing located between the probe and the cgm. There were no reported injuries, no one was exposed to the leak and no erroneous pt results were generated. Iris field svc engineer evaluated the instrument and replaced the tubing to resolve the leak. The fse ran controls which passed and system is operational.

 
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Brand NameICHEM VELOCITY
Type of DeviceAUTOMATED 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 Key4824174
MDR Text Key5841672
Report Number2023446-2015-00169
Device Sequence Number1
Product Code KQO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101852
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 05/01/2015
1 Device Was Involved in the Event
0 PatientS WERE 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 Received05/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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