MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM; CHEMISTRY ANALYZER

Catalog Number 1922814

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a non-reproducible, higher than expected, vitros troponin i es (tropi es) results were obtained from two different patient samples when tested on a vitros eciq immunodiagnostic system.The most likely assignable cause is instrument related.Within run vitros tropi es precision tests performed were outside ortho acceptable guidelines indicating that the vitros eciq immunodiagnostic system was not performing as expected at the time of the event.An ortho field engineer (fe) repeated a diagnostic within run vitros tropi es precision test on (b)(6) 2023 and again obtained results outside of ortho guidelines indicating the instrument was still not performing as expected at the time of the event.The ortho fe then performed service and maintenance actions on numerous subsystems of the vitros eciq system.These included replacing the signal reagent a and b pumps and all related tubing, signal reagent tips and nozzle body assembly, the well shuttle assembly and the vapor absorption cartridge and particle filter related to the puffer system.Following these service and maintenance actions, a 30 replicate within run precision test was performed by the ortho fe and this time the results obtained were within ortho acceptable guidelines indicating the vitros eciq imminodiagnostic system was now performing as expected.Additionally, following ortho fe actions, the customer also successfully processed quality control fluids and accepted the instrument back into routine use.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tropi es reagent lot 5190.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected, vitros troponin i es (tropi es) results were obtained from two different patient samples when tested on a vitros eciq immunodiagnostic system.Patient 1 result of 0.066 ng/ml versus the expected result of <0.012 ng/ml patient 2 result of 0.063 ng/ml versus the expected result of <0.012 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected, vitros tropi es results were not reported from the laboratory and ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18016084
• MDR Text Key: 326914542
• Report Number: 0001319681-2023-00059
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 10758750000272
• UDI-Public: 10758750000272
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1922814
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1