MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 3600 IMMUNODIAGNOSTIC SYSTEM; CHEMISTRY ANALYZER

Model Number	6802783
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report false non-reactive patient sample results were obtained when a single patient sample that was tested using vitros anti-hcv (ahcv) lot 5320 on a vitros 3600 immunodiagnostic system.The patient was known to be infected with hepatitis c, therefore the vitros ahcv results are false non-reactive results.Patient 1, vitros ahcv results of 0.74 and 0.65 s/c (non-reactive) versus the expected result of reactive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reactive vitros ahcv results for patient 1 were not reported from the laboratory.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 601630.
Additional Manufacturer Narrative
The investigation determined that false non-reactive patient sample results were obtained when a single patient sample was tested using vitros anti-hcv (ahcv) lot 5320 on a vitros 3600 immunodiagnostic system.The patient was known to be infected with hepatitis c, therefore the vitros ahcv results are false non-reactive results.The most likely cause of the event is an instrument related issue.High sd values were observed for the final well wash subsystem of the vitros 3600 immunodiagnostic system prior to service actions and an ortho field engineer (fe) replaced the final well wash motor, two filters and sr probes.Following ortho fe actions, a within-run diagnostic precision testing indicated acceptable instrument performance and an acceptable vitros ahcv result of 2.15 s/c (reactive) was obtained from the same sample for the patient.

• Brand Name: VITROS 3600 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: 16822744
• Report Number: 0001319681-2023-00027
• Device Sequence Number: 15168200
• Product Code: JJE
• UDI-Device Identifier: 10758750002979
• UDI-Public: 10758750002979
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (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): 04/26/2023

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 Model Number: 6802783
• Device Catalogue Number: 6802783
• 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: 03/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2019
• 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