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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH URINALYSIS SYSTEM; AUTOMATED URINALYSIS SYSTEM
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CARDINAL HEALTH 200, LLC CARDINAL HEALTH URINALYSIS SYSTEM; AUTOMATED URINALYSIS SYSTEM Back to Search Results
Model Number CH3050-17
Device Problems Display Difficult to Read (1181); Defective Device (2588); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2018
Event Type  malfunction  
Event Description
Urinalysis system slides have been faulty for 2 to 3 months.Product is listed as 10 chambered slides for urinalysis by cardinal health.Catalog number ch3050-17.Slides are warped and therefore will not stay "seated" on the microscope for microscopic exam of urine.Extremely difficult for techs to complete this testing, also may cause resulting errors as the warped slides are difficult to read.Manufacturer response for urinalysis slides, (brand not provided) (per site reporter) replaced product.
 
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Brand Name
CARDINAL HEALTH URINALYSIS SYSTEM
Type of Device
AUTOMATED URINALYSIS SYSTEM
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
785 fort mill hwy.
fort mill SC 29707
MDR Report Key7955968
MDR Text Key123567263
Report Number7955968
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCH3050-17
Device Catalogue NumberCH3050-17
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2018
Date Report to Manufacturer10/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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