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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY STRIP; URINE CHEMISTRY STRIP
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IRIS INTERNATIONAL ICHEM VELOCITY STRIP; URINE CHEMISTRY STRIP Back to Search Results
Catalog Number 800-7212
Device Problems False Negative Result (1225); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2015
Event Type  malfunction  
Event Description
Customer stated when looking at a newly open vial of velocity chemistry strips they noticed the chemistry pads were partially detached from the strips.When the strips are loaded into the spm, after mechanical movement the pads are falling off.There were no erroneous patient results generated or reported out of the lab.
 
Manufacturer Narrative
Customer technical support (cts) sent the customer replacement set of strips.The root cause of this event has not been determined to date.(b)(4).
 
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Brand Name
ICHEM VELOCITY STRIP
Type of Device
URINE CHEMISTRY STRIP
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4845234
MDR Text Key15591647
Report Number2023446-2015-00176
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K101852
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 05/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/05/2016
Device Catalogue Number800-7212
Device Lot Number7212081A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/14/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
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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