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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 False Negative Result (1225); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2015
Event Type  malfunction  
Event Description
Customer reported strip pads coming off.
 
Manufacturer Narrative
Customer reported strip pads coming off inside the instrument.There were no reports of erroneous pt results nor change to pt management or reports of injury to pt as a result.Iris field service engineer (fse) found a minor misalignment of the strip provider module (spm) wiper and extractor.The fse adjusted the height of the spm.The fse recommended the customer clean the spm more then twice weekly.The system was operational.
 
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Brand Name
ICHEM VELOCITY
Type of Device
AUTOMATED 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 Key4688778
MDR Text Key5676684
Report Number2023446-2015-00122
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeCA
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 03/11/2015
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 Expiration Date01/15/2016
Device Catalogue Number700-7177-001
Device Lot Number7212049A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2015
Initial Date FDA Received04/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2015
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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