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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 Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2016
Event Type  Malfunction  
Manufacturer Narrative

The investigation determined that 45 higher than expected amon results were obtained from both ortho and non-ortho biorad quality control fluids on a vitros 5600 integrated system the most likely assignable cause is an instrument issue related to incubator contamination based on pre-service within run precision testing performance higher than the guideline and acceptable post-service precision. An ortho field engineer performed service actions on the microslide incubator and replaced the evaporation caps, belt and wear pads. Following completion of maintenance actions significantly improved vitros amon precision performance was achieved using the same vitros amon reagent lot.

 
Event Description

A customer obtained 45 higher than expected vitros amon results from ortho and non-ortho biorad quality control fluids using vitros amon slide lot 1014-0239-3216 tested on a vitros 5600 integrated system. Vitros lpv i results of 90. 7 umol/l compared to an expected result of 45. 1 umol/l. Vitros lpv ii result of 256. 3 umol/l compared to an expected result of 199. 2 umol/l. Biorad liquicheck quality control fluid (lot#51962) results of 129. 6, 126. 5, 126. 1, 123, 122. 2, 121. 4, 121. 4, 121. 2, 120. 1, 119. 7, 118. 1, 117. 7, 116. 1, 115. 7, 112. 7, 111. 2, 111, 108. 9, 100. 4, 99. 1, 99, 98. 8, 97. 3, 97. 1, 115. 3, 131. 4, 128. 1, 127, 122. 1, 121, 120, 119. 5, 119. 2, 118. 7, 115. 1, 114. 9, 110. 1, 106. 6, 105. 2, 103, 100. 3, 99. 3, 96. 2 umol/l compared to an expected result of 80 umol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Ortho has not been made aware of any erroneous vitros amon results obtained or reported from the laboratory during the time frame of this event. However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (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 Key5485394
MDR Text Key40080905
Report Number1319681-2016-00042
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 Received02/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/12/2014
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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