MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 Integrated System; Clinical Chemistry

Catalog Number	6802413
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a sample metering event occurred where sample fluid was aspirated from the wrong tube/cup position of a sample tray for three different patient samples when tested on a vitros 5600 integrated system.Mis-associated patient results may lead to inappropriate physician action.The mis-associated patient sample results were not reported outside of the laboratory and there was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that a sample metering event occurred where sample fluid was aspirated from the wrong tube/cup position of a sample tray for three different patient samples when tested on a vitros 5600 integrated system.The assignable cause of the event was not yet determined; however, it is possible a hardware issue with the affected sample tray or a software or hardware issue with the vitros 5600 integrated system was the cause of the event.The investigation of the event at the site is ongoing.Additional review of the debug files collected from the vitros 5600 integrated system at the time the event occurred is ongoing.Once the investigation is completed, a follow-up regulatory report will be filed with the conclusion.

• Brand Name: VITROS 5600 Integrated System
• Common Device Name: Clinical Chemistry
• 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 ; +1(585)453-4165
• MDR Report Key: 24689643
• Report Number: 1319681-2026-00019
• Device Sequence Number: 15953570
• Product Code: JJE
• 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,Followup
• Report Date (Section B): 09/02/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2019
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Sex: Unknown