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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 Device Operates Differently Than Expected (2913); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2015
Event Type  malfunction  
Event Description
The customer reported they are failing ca quality control for bilirubin.There were no erroneous patient results generated or reported out of the lab.
 
Manufacturer Narrative
Iris field service eng.Was sent to the customer location.The fse observed no fluid in the tubing from the syringe to the pipette and discovered the syringe to the "t"-valve connection was loose.The fse tightened the connection to resolve the issue.The fse ran controls which passed and system was operational.(b)(4).
 
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Brand Name
ICHEM 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 Key4921918
MDR Text Key6434859
Report Number2023446-2015-00191
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
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 05/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 05/29/2015
Initial Date FDA Received06/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2013
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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