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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 1726926
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that non-reproducible, higher than expected vitros amon results were obtained from two different samples collected from the same patient processed on a vitros 5600 integrated system. The investigation was unable to determine a definitive assignable cause for this event. However, a sample related issue related to the affected patient cannot be ruled out. The issue is isolated only to samples drawn from the affected patient in question, as other patient samples run over this time frame did not demonstrate a similar issue. The patient is an oncology patient that was treated with multiple medications, including asparaginase, which is used in the treatment of some leukemias and lymphomas. It is possible the asparginase, or a combination of the asparginase and one of the additional medications is interfering with the vitros amon assay, although this could not be confirmed. Quality control and precision test results from the time frame of the event demonstrated acceptable within-laboratory and within-run performance of the vitros amon reagent lot 1018-0250-4413. With the exception of the non-reproducible results obtained from samples collected from the patient in question, vitros amon lot 1018-0250-4413 appeared to be performing within expectations. In addition, results of precision testing demonstrated that the vitros 5600 integrated system was performing as intended at the time of the event. The non-reproducible, higher than expected vitros amon results for sample 1 and 2 were not reported outside of the laboratory and there was no reported allegation of patient harm as a result of this event.
 
Event Description
A customer reported non-reproducible, higher than expected vitros ammonia (amon) results were obtained for two different samples collected from a single patient. The patient samples were processed on a single vitros 5600 integrated system. Sample 1: amon result of 241. 6, 343. 3, and 373. 8 umol/l vs. The expected result of 188. 2 umol/l. Sample 2: amon result of 310. 2 umol/l vs. The expected result of 257. 3 umol/l. The patient sample results when plotted on an error grid in wki53780, appendix 2, fall in the "inappropriate treatment likely; serious consequences not remote" section of the grid and therefore are reportable. 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 results were not reported outside of the laboratory and there was no allegation of patient harm. This report corresponds to ortho clinical diagnostics inc. Complaint number (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 Key8741356
MDR Text Key214532722
Report Number1319809-2019-00047
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 06/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2020
Device Catalogue Number1726926
Device Lot Number1018-0250-4413
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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