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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS DIAGNOSTICS ICHEM VELOCITY STRIP
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IRIS DIAGNOSTICS 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 01/14/2015
Event Type  malfunction  
Event Description
The customer reported they are failing quality control for bilirubin.The customer tried using new quality controls and a new lot of chemistry strips and the ca quality control for bilirubin did not pass.The customer indicated the chemistry pad was not getting dosed in the center.There were no erroneous patient results generated or reported out of the lab.
 
Manufacturer Narrative
Iris field service engineer was sent to the customer location.The fse observed no fluid in the cgm tubing and found a loose syringe body.The fse tightened the syringe body to valve connection 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 DIAGNOSTICS
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4921928
MDR Text Key6025346
Report Number2023446-2015-00187
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
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 01/14/2015
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 01/14/2010
Initial Date FDA Received06/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2013
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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