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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 Problem Loose or Intermittent Connection (1371)
Patient Problem Not Applicable (3189)
Event Date 12/21/2015
Event Type  malfunction  
Manufacturer Narrative
The customer found that the pads were coming aff the strips.A new set of strips was provided to the customer.(b)(4).
 
Event Description
The customer reported the pads were falling off the strips of the ichem velocity instrument.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection with this event.
 
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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 (Section G)
BECKMAN COULTER
11800 sw 147th ave
miami FL 33196
Manufacturer Contact
miranda holland
11800 sw 147th ave
32-s08
miami, FL 33196
3053802031
MDR Report Key5375631
MDR Text Key36277581
Report Number2023446-2016-00027
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,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2016
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
Date Manufacturer Received12/21/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/06/2014
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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