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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 Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2017
Event Type  Malfunction  
Manufacturer Narrative

The investigation determined that lower than expected vitros amon results were obtained when testing non-vitros quality controls on a vitros 5600 integrated system. The assignable cause of this event was instrument related. The results of a diagnostic within run vitros amon precision test was not acceptable indicating an instrument related issue. After service actions were completed to clean the evaporation caps and adjusting the slide align guides, the precision was acceptable indicating service actions had returned the analyzer to acceptable performance. The customer continued to obtain unacceptable amon results and an issue was identified involving the slide supply humidity affecting quality control results for multiple assays. After the ortho fe replaced the humidity plate, post-service quality control testing was acceptable indicating the actions have resolved the issue. Since unacceptable performance was observed for multiple reagents including vitros amon and acceptable performance was observed after the service actions using the current reagent lot, vitros amon lot 1017-0245-0578 can be ruled out as a contributing factor.

 
Event Description

The customer observed lower than expected vitros amon results when testing a non-vitros quality control fluid on a vitros 5600 integrated system. Biorad quality control level 3 lot 54193 vitros amon results 139. 1 and 145. 5 umol/l versus expected 259. 99 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The vitros amon results were obtained when testing non-vitros quality control samples. There was no allegation of patient harm as a result of the event. (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 Key6792806
MDR Text Key82938445
Report Number1319681-2017-00064
Device Sequence Number0
Product Code JIF
Combination Product (Y/N)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 08/14/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2017
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 Received07/17/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/09/2015
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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