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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INT'L ICHEM 1--; URINE CHEMISTRY ANALYZER
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IRIS INT'L ICHEM 1--; URINE CHEMISTRY ANALYZER Back to Search Results
Catalog Number 800-7000
Device Problems Device Operates Differently Than Expected (2913); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2013
Event Type  malfunction  
Event Description
The customer stated the last two digits of pt barcodes are being read incorrectly by the instrument.
 
Manufacturer Narrative
The customer stated the last two digits of pt barcodes are being read incorrectly by the instrument.There are no reports of erroneous results being generated or reported out of the lab.The customer was sent a replacement instrument to resolve the issue.The new system was operational.
 
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Brand Name
ICHEM 1--
Type of Device
URINE CHEMISTRY ANALYZER
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 Key4748982
MDR Text Key5827003
Report Number2023446-2015-00144
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060280
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 05/07/2013
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 Number800-7000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/07/2013
Initial Date FDA Received05/01/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2012
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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