MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802413
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	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, higher than expected troponin ies (tropies) result was obtained from a single patient sample using vitros troponinies reagent lot 5810 on a vitros 5600 integrated system.The assignable cause of the event is likely an instrument related issue.An ortho field engineer (fe) observed crystals on the signal reagent probes of the vitros 5600 system.The fe performed maintenance actions of the instrument including cleaning the signal reagent probes and cleaning the microwell sub-system.Following maintenance actions, a post service vitros tropi es within run precision test processed on the vitros 5600 system yielded results that were within ortho acceptable guidelines indicating that the performance of the vitros 5600 integrated system had been returned to expectations following the actions performed by the ortho fe.Based on historical quality control results, a vitros tropies lot 5810 performance issue is not a likely contributor to the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tropi es reagent lot 5810.However, the customer does not process a control fluid with a troponin i concentration at, or below the url.Therefore, the performance of the vitros tropies reagent lot 5810 at, or below the url concentration of 0.034 ng/ml (ug/l) cannot be determined and a reagent issue could not be entirely ruled out as contributing to the event.
Event or Problem Description
An ortho field application specialist contacted ortho on behalf of a customer to report a non-reproducible, higher than expected troponin i es (tropies) result was obtained from a single patient sample using vitros troponinies reagent lot 5810 on a vitros 5600 integrated system.Patient sample result of 5.170 ng/ml vs.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 tropies result was not reported from the laboratory.There has been no reported 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 5600 INTEGRATED 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21877476
• Report Number: 1319681-2025-00021
• Device Sequence Number: 8768640
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: 6802413
• 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: 03/24/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• 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