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

Catalog Number	6802413
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that quality control results shifted low on a single level of non-vitros biorad control using multiple vitros microwell assays on a vitros 5600 integrated system.Although multiple microwell assays were affected, only results obtained from the vitros ckmb and nbnp2 assays the criteria for a reportable event.The investigation concluded the cause of the event was an instrument related issue.Multiple vitros microwell assays were affected, and expected performance was obtained after an ortho service event where an ortho field engineer (fe) performed routine maintenance (maintenance actions not provided) and recalibration of the assays.Since the issue was resolved by the routine maintenance and recalibrations performed by the ortho fe, this indicates a performance issue with the vitros 5600 integrated system was the cause of the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report quality control results shifted low on a single level of non-vitros biorad control using multiple vitros microwell assays on a vitros 5600 integrated system.Although multiple microwell assays were affected, only results obtained from the vitros ckmb and nbnp2 assays met potential health and safety criteria.Vitros ckmb assay, reagent lot: 3910 non-vitros biorad control lot: 1003100 level 1 result of 3.24 ng/ml vs.The expected result of 8.50 ng/ml vitros nbnp2 assay, lot: 2150 non-vitros biorad control lot: 1003100 level 1 result of 37.85 pg/ml vs.The expected result of 150.2 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 ckmb and nbnp2 results were obtained from non-patient quality control samples.Patient samples were not affected and there was no allegation of harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23607981
• Report Number: 1319681-2025-00056
• Device Sequence Number: 13241280
• 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): 11/20/2025

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: 10/27/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2019
• 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