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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 Problems High Test Results (2457); Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2017
Event Type  Malfunction  
Manufacturer Narrative

The investigation determined that a lower and higher than expected vitros amon results were obtained when testing non-vitros quality controls on a vitros 5600 integrated system. Biorad qc level 2 amon result 103. 7 umol/l versus expected 75. 5 umol/l. Biorad qc level 3 amon result of 15. 7 umol/l versus expected 227. 7 umol/l. The assignable cause of this event was instrument related most likely due to incubator contamination. The customer completed an incubator decontamination procedure including cleaning/replacing the incubator evaporation caps and slots, and returned the instrument to expected operation. Following this activity, acceptable vitros amon performance was observed.

 
Event Description

The customer observed lower and higher than expected vitros amon results when testing non-vitros quality control fluids on a vitros 5600 integrated system. Biorad qc level 2 amon result 103. 7 umol/l versus expected 75. 5 umol/l. Biorad qc level 3 amon result of 15. 7 umol/l versus expected 227. 7 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. However, the investigation cannot conclude that patient samples were not affected or 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 Key6730324
MDR Text Key80762643
Report Number1319681-2017-00054
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 MEDICAL TECHNOLOGIST
Type of Report Initial
Report Date 07/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/20/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/28/2012
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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