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

Catalog Number	1922814
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, higher than expected, vitros troponin i es (tropi es) result was obtained from a single patient sample 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 identified extensive incubator contamination and performed service, maintenance and cleaning actions to the instrument, including removing the incubator and cleaning all visible contamination, replacing the well weight, the evaporation cover, the fiberoptic bundle assembly, signal reagent pump, probes, tips and tubing and the inner lift pin due to observed damage and contamination and optimizing well wash, signal reagent and incubator adjustments.Following extensive service and cleaning actions, an acceptable vitros tropi es within run diagnostic precision test performed was within ortho acceptable guidelines indicating the vitros eciq imminodiagnostic system was now performing as expected.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tropi es reagent lot 5000.
Event or Problem 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) result was obtained from a single patient sample when tested on a vitros eciq immunodiagnostic system.Patient sample 1 result of 0.166 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 result was reported from the laboratory.No treatment was altered, initiated or stopped based on the reported result and a corrected report was later issued for the patient.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
• Common Device Name: 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: 17640779
• Report Number: 0001319681-2023-00044
• Device Sequence Number: 7978976
• Product Code: KHO
• UDI-Device Identifier: 10758750000272
• UDI-Public: 10758750000272
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1922814
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown