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

Catalog Number 6802413

Device Problem Low Test Results (2458)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros nbnp2 results were obtained when processing a non-vitros quality control fluid on a vitros 5600 integrated system.Biorad cardiac markers plus lot 67693: vitros nbnp2 results 2221.5 and 2022.7 pg/ml versus the baseline mean 2975 pg/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected results were obtained from a non-patient quality control sample.The customer did not report any allegations 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).

Manufacturer Narrative

The investigation determined that lower than expected vitros nbnp2 results were obtained when processing a non-vitros quality control fluid on a vitros 5600 integrated system.The cause of the lower than expected results was due to an issue with the vitros 5600 integrated system.The historical vitros nbnp2 quality control results were acceptable in regard to both accuracy and within laboratory precision prior to the event.In addition, the quality control results for vitros nbnp2 lot 0200 were acceptable on the other vitros 5600 integrated system in the customer's laboratory when using the same quality control fluids ruling out an assay issue as the cause of the event.The ortho field engineer (fe) performed service actions on the vitros 5600 integrated system including replacing the waste connectors from the fluid manifold to the waste cap, all three microwell incubator driver motors, each incubator ring wear pads and the well wash linear motors and the nozzles.The ortho fe cleaned and rebuilt the pre and final well wash assemblies and performed all required adjustments.A full luminometer calibration was performed, and all required assay calibrations were performed.Once service actions were completed, the ortho fe attempted to perform post service within-run precision testing, however, the precision testing could not be completed due to mechanical failures.Further service actions are required to mitigate the instrument performance issues.The ortho fe will return to the customer site to complete all service actions which are expected to return the vitros 5600 system to the intended performance.

• Brand Name: VITROS 5600 INTEGRATED 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18828753
• MDR Text Key: 337315482
• Report Number: 1319681-2024-00018
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: 10758750002740
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6802413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1