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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER

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ORTHO-CLINICAL DIAGNOSTICS VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER Back to Search Results
Catalog Number 6802413
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2016
Event Type  Malfunction  
Manufacturer Narrative

The investigation has determined that higher than expected amon results were obtained from non vitros quality control fluids using vitros amon reagent on a vitros 5600 integrated system. A likely assignable cause for the higher than expected amon results is user error due to pre-analytical sample handling. Acceptable performance was obtained when fresh pours of control fluids that were properly handled were retested. There was no indication the vitros amon reagent or the vitros 5600 system malfunctioned.

 
Event Description

The customer obtained higher than expected amon results from two levels of non vitros quality control fluids using vitros amon reagent on a vitros 5600 integrated system. Level 1 vitros amon result 112 umol/l versus the expected amon result 80. 3 umol/l level 2 vitros amon result 301 umol/l versus the expected amon result 212 umol/l biased results of the direction and magnitude observed may lead to inappropriate physician action. The customer stated that vitros amon patient samples were not processed during the time frame of the event. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).

 
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Brand NameVITROS 5600 INTEGRATED SYSTEM
Type of DeviceCHEMISTRY ANALYZER
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer Contact
james a stevens
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key5442829
MDR Text Key38998801
Report Number1319681-2016-00029
Device Sequence Number0
Product Code JIF
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 02/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2016
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6802413
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/25/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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