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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 04/12/2015
Event Type  Malfunction  
Event Description

Customer stated their qc was failing and there was a leak on top of the spm.

 
Manufacturer Narrative

The customer stated their controls are failing and they found liquid on top of the strip provider module (spm) and in the waste bin. There are no reports of erroneous results generated or reported out of the lab. There are no reported injuries or exposure to the leak. Iris field service engineer (fse) was sent to the customer location and replaced tubing to resolve the leak. The fse re-ran controls and controls passed, the system was 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 Key4763466
MDR Text Key5948596
Report Number2023446-2015-00153
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 04/12/2015
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 Received04/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2013
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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