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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2016
Event Type  Malfunction  
Manufacturer Narrative

The investigation determined that a lower than expected ammonia quality control result was obtained from a non-vitros quality control fluid using vitros amon reagent with a vitros 5600 integrated system. The most likely assignable cause of the lower than expected quality control result is instrument related. Vitros amon precision testing performed was outside of ortho guidelines, indicating that the vitros 5600 integrated system was not performing as intended at the time of the events. The cause of the unexpected instrument performance is likely due to microslide incubator contamination. An ortho clinical diagnostics field engineer performed service actions to return the vitros 5600 integrated system to expected performance. Following these service actions, acceptable vitros amon performance was observed.

 
Event Description

A customer obtained a lower than expected ammonia quality control result (114. 79 umol/l vs. Expected result of 162. 8 umol/l) from a non-vitros quality control fluid, using vitros amon reagent with a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected ammonia result was generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the 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 Key5485753
MDR Text Key40136913
Report Number1319681-2016-00044
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 03/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/08/2016
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 Received02/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/29/2014
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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