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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 05/23/2016
Event Type  Malfunction  
Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected amon result was obtained from a quality control fluid when using a vitros 5600 integrated system. The most likely assignable cause is an instrument issue related to incubator contamination. Following maintenance actions by an ortho field engineer, vitros amon within-lab precision and within-run precision were significantly improved.

 
Event Description

A customer reported a non-reproducible, lower than expected amon result obtained on a quality control fluid processed using a vitros 5600 integrated system. Amon result = 150. 0 umol/l vs. Expected 199. 2 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples. The customer made no allegation that amon patient results were affected. There was no allegation of patient harm. (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 Key5745194
MDR Text Key49157647
Report Number1319681-2016-00156
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 06/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2016
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 Received05/26/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/25/2010
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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