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

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).

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Type of Device: IN 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 Key: 8741356
• MDR Text Key: 214532722
• Report Number: 1319809-2019-00047
• Device Sequence Number: 1
• Product Code: JID
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0250-4413
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1