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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN VITRO DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1721869
Device Problem High Readings (2459)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation concluded that a higher than expected result was obtained from a single patient sample using vitros amon micro slides on a vitros 5600 integrated system. The investigation could not determine the assignable cause of the event. The samples were processed within 12 minutes on both systems; therefore, improper pre-analytical sample handing did not likely contribute to the event. There were no historical quality control results available to access the performance of the amon lot on the affected vitros 5600 system. However, ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros amon reagent lot 1017-0248-5923. A vitros amon within-run precision test was acceptable for both accuracy and precision, indicating an analyzer related issue did not likely contribute to the event. However, only a single level of quality control was processed for the precision test, and it is unknown if the calibration in use was acceptable across the amon measuring range. Therefore, it is possible the event was due to calibration to calibration variation.
 
Event Description
A customer reported unexpected results obtained from a patient sample correlation performed between two different vitros 5600 integrated systems using vitros clinical chemistry products ammonia (amon) slides. Patient sample result of 94 umol/l vs. The expected result of 77 umol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected patient sample result was not reported outside of the laboratory and there was no allegation of patient harm. This report corresponds to ortho clinical diagnostics inc. (b)(4).
 
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Brand NameVITROS CHEMISTRY PRODUCTS AMON SLIDES
Type of DeviceIN VITRO DIAGNOSTICS
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
513 technology blvd.
rochester NY 14652
Manufacturer Contact
james a stevens
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key7967333
MDR Text Key126114926
Report Number1319809-2018-00113
Device Sequence Number1
Product Code JID
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 10/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2019
Device Catalogue Number1721869
Device Lot Number1017-0248-5923
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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