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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 Tube (525); Fluid Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2015
Event Type  Malfunction  
Event Description

The customer stated there is a uncontained leak coming fromthe cgm syringe tube.

 
Manufacturer Narrative

Customer reported the ichem velocity had a crack in the cgm syringe tube causing an uncontained leak. There were no reported injuries, no one was exposed to the leak, and no erroneous patient results were generated. Iris field service engineer evaluated the instrument and replaced the cracked tubing resolved the probe 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 INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4763468
MDR Text Key5948597
Report Number2023446-2015-00152
Device Sequence Number1
Product Code KQO
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK101852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/05/2015
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 Received04/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2014
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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