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	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected results were obtained when non-vitros qcs were processed using vitros nbnp2 and vitros ckmb2 on a vitros 5600 integrated system.Vitros nbnp2, mas level 1 (lot 27041) results of 128.88, 219.67, 236.09, 219.13, 207.59, 175.37, 170.78 and 180.57 pg/ml versus the baseline mean result of 335.5 pg/ml vitros nbnp2, mas level 3 (lot 27043) result of 5863.69 pg/ml versus the baseline mean result of 7472.0 pg/ml vitros ckmb2, mas level 1 (lot 27041) results of 1.16, 2.37, 2.16, 2.15, 2.08, 1.88, 1.52 and 1.23 ng/ml versus the baseline mean result of 3.67 ng/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 vitros results were obtained when the customer was processing non-patient fluids.There has been no 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).
Additional Manufacturer Narrative
The investigation determined that lower than expected results were obtained when non-vitros qcs were processed using vitros nbnp2 and vitros ckmb2 on a vitros 5600 integrated system.The assignable cause of the event is an instrument issue.Lower than expected results from multiple vitros microwell assays were obtained from multiple qc fluids on the instrument pre-service actions.An ortho field engineer (fe) performed service actions on the instrument including rebuilding of the preliminary and final well wash substations, cleaning of the microwell incubator, replacement of the linear stepper motor and calibration of the luminometer.The qc results from the multiple vitros microwell assays were acceptable post-fe service actions.

• 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: 25315815
• Report Number: 1319681-2026-00035
• Device Sequence Number: 18673968
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2018
• 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