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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INT'L ICHEM VELOCITY STRIP

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IRIS INT'L ICHEM VELOCITY STRIP Back to Search Results
Catalog Number 700-7177-001
Device Problems Tube (525); Crack (1135); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/21/2015
Event Type  Malfunction  
Event Description

Customer stated they are failing ca control for bilirubin.

 
Manufacturer Narrative

Customer reported the ichem velocity had a crack in the cgm syringe tube causing an ca control failure for bilirubin. There were no reported injuries and no erroneous patient results were generated or reported out of the lab. Iris field service engineer evaluated the instrument and replaced the cracked tubing resolving the control failure. The fse ran controls which passed and system is operational.

 
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Brand NameICHEM VELOCITY STRIP
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 Key4798174
MDR Text Key5829773
Report Number2023446-2015-00158
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 04/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2015
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 Received04/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2014
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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